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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
FOR ANNUAL AND TRANSITION REPORTS PURSUANT TO
SECTIONS 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
(Mark One)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934.
For the fiscal year ended December 31, 1998
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OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES
EXCHANGE ACT OF 1934.
Commission File No. 0-22373
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VAXCEL, INC.
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(Exact name of Registrant as specified in its charter)
Delaware 58-2027283
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(State or other jurisdiction (I.R.S. Employer Identification No.)
of incorporation or organization)
154 Technology Parkway
Norcross, Georgia 30092 30092
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (770) 453-0195
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Securities registered pursuant to Section l2(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act: Common Stock, $.001
par value per share
Indicate by check mark whether the Registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months and (2) has been subject to such filing requirements for
the past 90 days. YES X NO
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Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K is not contained herein, and will not be contained, to the
best of the Registrant's knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K. [X]
On March 22 1999, the aggregate market value of the Registrant's common stock
held by non-affiliates was approximately $86,000.
On March 22 1999, there were 10,994,656 shares of the Registrant's common stock
outstanding, exclusive of treasury shares.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Vaxcel, Inc. Proxy Statement for the 1999 Annual Meeting of
Stockholders (the "Proxy Statement") are incorporated by reference into Part
III.
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THIS FORM 10-K AND OTHER STATEMENTS ISSUED OR MADE FROM TIME TO TIME BY
VAXCEL, INC. OR ITS REPRESENTATIVES CONTAIN STATEMENTS WHICH MAY CONSTITUTE
"FORWARD-LOOKING STATEMENTS" WITHIN THE MEANING OF THE SECURITIES ACT OF 1933,
AS AMENDED (THE "1933 ACT"), AND THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED. THOSE STATEMENTS INCLUDE STATEMENTS REGARDING THE INTENT, BELIEF OR
CURRENT EXPECTATIONS OF VAXCEL, INC. AND MEMBERS OF ITS MANAGEMENT TEAM, AS WELL
AS THE ASSUMPTIONS ON WHICH SUCH STATEMENTS ARE BASED. PROSPECTIVE INVESTORS ARE
CAUTIONED THAT ANY SUCH FORWARD-LOOKING STATEMENTS ARE NOT GUARANTEES OF FUTURE
PERFORMANCE AND INVOLVE RISKS AND UNCERTAINTIES, AND THAT ACTUAL RESULTS MAY
DIFFER MATERIALLY FROM THOSE CONTEMPLATED BY SUCH FORWARD-LOOKING STATEMENTS.
THE COMPANY UNDERTAKES NO OBLIGATION TO UPDATE OR REVISE FORWARD-LOOKING
STATEMENTS TO REFLECT CHANGED ASSUMPTIONS, THE OCCURRENCE OF UNANTICIPATED
EVENTS OR CHANGES TO FUTURE OPERATING RESULTS OVER TIME.
PART I
ITEM 1. BUSINESS
GENERAL
Vaxcel, Inc., a Delaware corporation ("Vaxcel" or the "Company"), was
formed on January 6, 1993 as a wholly-owned subsidiary of CytRx Corporation
("CytRx"). In May 1997, Vaxcel completed a merger with Zynaxis, Inc.
("Zynaxis"), resulting in the issuance of an aggregate of 12.5% of its
outstanding (post-merger) shares of common stock to the former shareholders of
Zynaxis (see Note 3 to Financial Statements).
Vaxcel is engaged in the development and commercialization of vaccine
adjuvants and delivery systems and a novel vaccine for the treatment of cancer.
The Company has four proprietary adjuvant and delivery system technologies which
can be used to increase the effectiveness and/or convenience of both currently
marketed and new vaccines. Vaxcel's business strategy is to sublicense these
adjuvant and delivery system technologies on a vaccine-by-vaccine basis to
companies engaged in vaccine development. However, as discussed below, the
Company's ability to survive as a going concern is subject to a number of
uncertainties.
CURRENT FINANCIAL CONDITION AND THE POTENTIAL IMPACT ON OPERATIONS
At December 31, 1998, the Company had negligible cash and cash
equivalents and a working capital deficit of $304,000. The Company has obtained
loans from CytRx pursuant to certain convertible notes (see Item 13 "Certain
Relationships and Related Transactions") to allow it to meet its critical
financial obligations, however, the Company's current cash resources, together
with the proceeds of these loans are not sufficient to fund its operations
beyond the second quarter of 1999. The Company has incurred losses from
operations since its inception, and there is substantial doubt about the
Company's ability to survive as a going concern.
In May 1998, the Company's Board of Directors retained the investment
banking firm of Interstate/Johnson Lane Corporation to introduce Vaxcel and its
technology licenses to the trade with the purpose of concluding a strategic
transaction or transactions for the benefit of the Vaxcel stockholders. In order
to fund its operations and technologies, the Company will consider all available
options, including the possible sale of the Company to, or merger with, another
organization. In January 1999, the Company entered into an option agreement for
the sale of its PLG microencapsulation technology (see "Product Development"
below and Note 5 to Financial Statements).
The Company has severely reduced its operations, limiting its ability
to advance its technologies under development. For the Company to continue as a
going concern, it may need to obtain funds through arrangements that require it
to relinquish rights to certain or all of its technologies. The Company may be
required to totally cease operations and liquidate remaining assets, if any.
Should the Company determine that it is no longer in the best interest of its
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stockholders to continue operations, the ability of the Company to fund an
orderly disposition of assets, pay off its then outstanding liabilities and
return any remaining cash to its shareholders will be limited by the amount of
working capital on hand.
PRODUCT DEVELOPMENT
Vaxcel has a portfolio of proprietary adjuvants and delivery systems as shown
below.
<TABLE>
<CAPTION>
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TECHNOLOGY COMPOSITION ROUTE OF ADMINISTRATION
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<S> <C> <C>
Optivax(R) Block Copolymers Injectable
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Microencapsulation Poly(Lactide-Co-Glycolide) Oral & Mucosal
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Mucoadhesives Mucoadhesive Polymers Oral
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Entrapment Water Soluble Polymers Oral, Mucosal, & Injectable
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</TABLE>
Optivax is the tradename for a family of proprietary nonionic block
copolymers which augment or modify the immune response to vaccines when
administered primarily by injection. Optivax acts both as a delivery system by
targeting vaccines to cells of the immune system and as an adjuvant because of
its ability to augment the immune system's response to vaccines.
The PLG microencapsulation oral technology is based on the use of
lactide and glycolide polymers. The actual encapsulation process involves the
trapping of antigens into pockets or cavities formed within the PLG microspheres
during production. When the final vaccine is administered to humans, the PLG
microspheres degrade and the encapsulated antigen is then released to the
appropriate immunological site in the body. In January 1999, the Company entered
into an option agreement for the sale of this technology (see Note 5 to
Financial Statements).
Mucoadhesives are natural or synthetic polymers that bind to mucosal
tissues or the mucin that coats these tissues. Mucoadhesive polymers have been
favorably evaluated by others for oral delivery of drugs and Vaxcel believes
this technology may have application for vaccines.
In December 1997, Vaxcel and Vanderbilt executed a Research Agreement
and an Option Agreement to evaluate Vanderbilt's technology for vaccine delivery
by entrapping antigens into the structure of particles composed of water
soluble, biocompatible and/or biodegradable polymers. Under the terms of these
agreements, Vaxcel has the right to negotiate an exclusive, worldwide license to
further develop and market Vanderbilt's technology in the vaccine field.
Vaxcel's business strategy is to sublicense its technologies on a
vaccine-by-vaccine basis to companies engaged in vaccine development. See
"Corporate Collaborations". Amounts spent for research and development
activities for Vaxcel's adjuvant and delivery system technologies were $916,000,
$1,165,000 and $853,000 during the years ended December 31, 1998, 1997, and
1996, respectively.
Corporate Collaborations. The Company has three corporate collaboration
agreements for the development of its technologies:
Heska. In August 1998, Vaxcel signed a definitive license agreement with
Heska Corporation ("Heska") for use of Vaxcel's microencapsulation oral
technology in veterinary vaccines being developed by Heska. Heska is a
publicly-traded animal health products company based in Fort Collins,
Colorado.
Under the terms of the agreement, Heska received worldwide, non-exclusive
rights to the microencapsulation oral technology for use with eight
vaccines, currently being developed by Heska for use in dogs and cats. For a
period of two years after the execution of the license agreement, Heska has
option of converting their rights to be exclusive within selected fields and
to request licenses for additional fields. Heska or their corporate partners
will be responsible for conducting all development, manufacture regulatory
submissions and marketing activities for their vaccines that utilize the
microencapsulation oral technology. Vaxcel received an initial license
payment and additional payments will be due upon the conversion of
non-exclusive rights to exclusive. If vaccines are successfully developed
under the agreement, Vaxcel will receive milestone payments and royalties on
sales of such vaccines.
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Corixa. In April 1996, Vaxcel signed a definitive license agreement with
Corixa Corporation ("Corixa") for use of Vaxcel's Optivax in combination
with vaccines being developed by Corixa. Corixa, a publicly-traded
Seattle-based biotechnology company, is discovering and developing T-cell
therapeutic vaccines for the treatment of certain infectious diseases and
cancer.
Under terms of the agreement, Corixa received worldwide, exclusive
rights to use Optivax with a variety of cancer and infectious disease
vaccines being developed by Corixa. Corixa also has the right to sublicense
vaccines containing Optivax. Corixa or its sublicensees will be responsible
for conducting all development, regulatory submissions and marketing
activities for their vaccines combined with Optivax. In return, if vaccines
are successfully developed, Vaxcel will receive milestone payments,
royalties on sales of such vaccines, and payments under a supply agreement
for having Optivax manufactured for Corixa or its sublicenses.
ALK. Vaxcel assumed an agreement with ALK A/S ("ALK") as a result of its
merger with Zynaxis. ALK is a world leader in the preparation and
standardization of allergen extracts for allergy immunotherapy. In September
1995, ALK executed a development and licensing agreement to evaluate and
develop oral technologies for delivery of bioactive substances for the
treatment of allergy.
Vaxcel may receive additional milestone and royalty payments from ALK if
ALK receives Food and Drug Administration ("FDA") or certain other
regulatory approvals for allergy products using the oral vaccine delivery
technologies. Under the terms of this agreement, ALK is responsible for
conducting all development, regulatory submissions and marketing activities
for ALK's allergy products using the oral technologies. In addition, ALK has
the right to make or have made the PLG microspheres.
Cancer Vaccine Antigen. In March 1998, Vaxcel and University College
London ("UCL") executed a definitive license agreement whereby Vaxcel acquired
worldwide, exclusive rights to genetically engineered and mutated (beta)-Human
Chorionic Gonadotropin ((beta)hCG) proteins for use in the treatment and/or
prevention of cancer. UCL retained the rights to these (beta)hCG proteins for
therapeutic applications other than cancer. Under the terms of this license
agreement, Vaxcel paid UCL an upfront license fee upon execution of this license
agreement and will further pay UCL a royalty on net sales of any cancer product
that utilizes the (beta)hCG proteins. Vaxcel also has the right to sublicense
the (beta)hCG proteins, subject to certain conditions and the payment to UCL of
a fixed proportion of the sublicense compensation received by Vaxcel. Vaxcel
believes these proteins can be combined with the Company's Optivax adjuvant
technology to develop a next generation (beta)hCG cancer vaccine.
Except for pregnant women, healthy individuals do not normally produce
(beta)hCG. However, significant quantities of (beta)hCG are produced by many
different types of cancers including pancreatic, colorectal, breast, lung,
prostate, and others. The highest concentrations of (beta)hCG are secreted by
cancers which have metastasized. Research has indicated that cancer cells may
use (beta)hCG as one of the mechanisms to resist being attacked and killed by
the human immune system.
By combining these genetically engineered and mutated (beta)hCG
proteins from UCL with the Company's Optivax adjuvant, Vaxcel believes that both
the antigen and adjuvant components of this cancer vaccine should be superior to
a first generation (beta)hCG vaccine being developed with some encouraging
results by a third party. The genetically engineered and mutated (beta)hCG
proteins should be more immunogenic than the first generation vaccine and the
inclusion of the Optivax adjuvant in the vaccine formulation should help augment
anti-tumor cellular immune responses.
PATENTS AND PROPRIETARY TECHNOLOGY
Vaxcel actively seeks patent protection for its technologies,
processes, and uses, and considers its patents and other intellectual property
to be critical to its business.
Vaxcel has received a worldwide, exclusive license from CytRx for the
use of a series of certain copolymers as a vaccine adjuvant/delivery system. See
Item 13 - "Certain Relationships and Related Transactions." These patents and
patent applications contain claims directed to the use of copolymers as vaccine
adjuvants/delivery systems and the use of the copolymers in any vaccine
preparation.
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The compositions and methods for the administration of bioactive agents
to and through the Peyer's Patches by means of microencapsulation in
biocompatible, biodegradable microspheres of 1-10 microns in diameter are
protected by issued United States patents and foreign counterparts held by
Southern Research Institute ("SRI") and the University of Alabama at Birmingham
("UAB"). This microencapsulation technology is exclusively licensed to Vaxcel in
the field of oral vaccine delivery. In January 1999, the Company entered into an
option agreement for the sale of this technology (see Note 5 to Financial
Statements).
Vaxcel also has rights to pending United States patent applications and
foreign counterparts relating to the use of polymeric mucoadhesives for the oral
delivery of vaccines at mucosal surfaces and compositions and methods for
preparation of solid, orally administered dosage units for live viral vaccines.
Patent applications on the genetically engineered and mutated (beta)hCG
proteins were submitted by UCL in 1995. The claims in these patent applications
are directed to both composition of matter and therapeutic uses of the
recombinant, mutated (beta)hCG proteins.
In 1997, Vanderbilt submitted patent applications on its techniques for
entrapping antigens into the structure of particles composed of water soluble,
biocompatible and/or biodegradable polymers. The claims in these patent
applications are directed to both composition of matter and delivery of vaccines
and other substances.
Vaxcel also attempts to protect its proprietary products, processes and
other information by relying on trade secrets and non-disclosure agreements with
its current and former employees, consultants and certain other persons who have
access to such products, processes and information. Nevertheless, there can be
no assurance that these agreements will afford significant protection against
misappropriation or unauthorized disclosure of Vaxcel's trade secrets and
confidential information.
GOVERNMENT REGULATION
The manufacture and sale of any product based on Vaxcel's vaccine
adjuvants and delivery systems or its (beta)hCG cancer proteins will be subject
to extensive regulation by United States and foreign governmental authorities.
The FDA has established guidelines and safety standards which apply to the
pre-clinical evaluation, clinical testing, manufacture and marketing of
pharmaceutical products. The process of obtaining FDA approval for a new
therapeutic or prophylactic product (drug and/or vaccine) generally takes
several years and involves the expenditure of substantial resources. The steps
required before such a product can be produced and marketed for human use in the
United States include preclinical studies in animal models, the filing of an
Investigational New Drug ("IND") application, human clinical trials and the
submission and approval of a Product License Application ("PLA"). The PLA
involves considerable data collection, verification and analysis, as well as the
preparation of summaries of the manufacturing and testing processes, preclinical
studies, and clinical trials. The FDA must approve the PLA before the drug may
be marketed. There can be no assurance that the Company will be able to obtain
the required FDA approvals for any of its products.
The manufacturing facilities and processes for the Company's products,
whether manufactured directly by the Company or by a third party, will be
subject to rigorous regulation, including the need to comply with Federal Good
Manufacturing Practice regulations. The Company is also subject to regulation
under the Occupational Safety and Health Act, the Environmental Protection Act,
the Nuclear Energy and Radiation Control Act, the Toxic Substance Control Act
and the Resource Conservation and Recovery Act.
COMPETITION
Many companies, including large pharmaceutical, chemical and
biotechnology firms with financial resources, research and development staffs,
and facilities that are substantially greater than those of the Company, are
engaged in the research and development of pharmaceutical products that could
compete with the products under development by the Company. The industry is
characterized by rapid technological advances and competitors may develop their
products more rapidly and/or such products may be more effective than those
under development by the Company or its licensees and corporate partners.
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MANUFACTURING
Vaxcel currently does not have the capabilities to manufacture any of
its vaccine delivery/adjuvant technologies or its (beta)hCG proteins and plans
to rely upon collaborators and/or contract manufacturers to produce both its
technologies and final vaccine products for preclinical, clinical, and
commercial purposes. Currently, Vaxcel is not actively developing its
technologies or products and is not conducting any preclinical studies or
clinical trials with respect to such technologies and products. Vaxcel is also
not marketing or distributing any of such technologies or products on a
commercial scale. If Vaxcel decides to further develop its technologies and
products, there can be no assurance that third parties or collaborators would
be willing or able to manufacture such technologies or products in accordance
with GMP conditions and in quantities required by Vaxcel to satisfy its needs.
ENVIRONMENTAL PROTECTION
During 1998, compliance with federal, state and local regulations
pertaining to environmental standards did not have a material effect upon the
capital expenditures or earnings of the Company.
EMPLOYEES
During 1998, as part of its cash conservation measures, the Company
terminated the services of all of its research and development staff. The
Company currently employs only one individual, who serves in the capacity of
President & Chief Executive Officer on a part-time basis. The Company also
utilizes the services of two CytRx executives, pursuant to a services and
facilities agreement. See Item 13 - "Certain Relationships and Related
Transactions."
ITEM 2. PROPERTIES
Vaxcel currently leases administrative space from CytRx pursuant to a
services and facilities agreement. Such space is adequate for Vaxcel's needs.
See Item 13 - "Certain Relationships and Related Transactions."
ITEM 3. LEGAL PROCEEDINGS
None
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
The Company's Common Stock is traded on the OTC Bulletin Board under
the symbol VXCL. The following table sets forth the high and low bid information
for the Common Stock for the periods indicated as reported by the OTC Bulletin
Board. Such prices represent bids between dealers without adjustment for retail
mark-ups, mark-downs, or commissions and may not necessarily represent actual
transactions.
<TABLE>
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High Low
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COMMON STOCK:
1999:
January 1 to March 22 1/8 1/16
1998:
Fourth Quarter 1/8 1/16
Third Quarter 5/8 1/8
Second Quarter 1 1/32 15/32
First Quarter 11/16 1/2
1997
Fourth Quarter 1 3/8
Third Quarter 1 3/4 5/8
Second Quarter (from May 21) 2 1/8 1 1/4
</TABLE>
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On March 22, 1999, the closing bid quotation of the Common Stock as
reported on the OTC Bulletin Board was $1/16 and there were approximately 275
holders of record of the Company's Common Stock. The number of record holders
does not reflect the number of beneficial owners of the Company's Common Stock
for whom shares are held by Cede & Co., certain brokerage firms and other
institutions. The Company has not paid any dividends since its inception and
does not contemplate payment of dividends in the foreseeable future.
ITEM 6. SELECTED FINANCIAL DATA
<TABLE>
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1998(a) 1997(b) 1996 1995 1994
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<S> <C> <C> <C> <C> <C>
Statement of Operations Data:
Total revenues $ 254,471 $ 288,504 $ 135,563 $ 178,707 $ 508,886
Net loss (4,993,289) (2,599,298) (1,124,183) (1,378,805) (599,843)
Basic and diluted loss per common share (.45) (0.26) (0.14) (0.17) (0.09)
Balance Sheet Data:
Total assets $ 976,287 $ 5,458,210 $ 377,992 $ 701,868 $ 1,043,575
Total stockholders' equity 358,161 5,291,450 159,986 584,169 962,974
</TABLE>
(a) Includes a $3,212,000 impairment loss related to acquired developed
technology and goodwill.
(b) Includes a $951,000 charge for acquired incomplete research and
development.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
Liquidity and Capital Resources
At December 31, 1998, the Company had cash and cash equivalents of
$2,900 and net assets of $358,000, as compared to $691,000 and $5,291,000,
respectively, at December 31, 1997. At December 31, 1998 the Company had a
working capital deficit of $304,000.
The Company is critically short of cash to fund its operations. The
Company has incurred losses from operations since its inception, and there is
substantial doubt about the Company's ability to survive as a going concern. As
discussed below, the Company has obtained loans from CytRx pursuant to certain
convertible notes and has received additional payments subsequent to year-end
pursuant to a certain option agreement. However, the Company's current cash
resources, together with the proceeds of these transactions are not sufficient
to fund its operations beyond the second quarter of 1999.
The Company has severely reduced its operations, limiting its ability
to advance its technologies under development. For the Company to continue as a
going concern, it may need to obtain funds through arrangements that require it
to relinquish rights to certain or all of its technologies. The Company may be
required to totally cease operations and liquidate remaining assets, if any.
Should the Company determine that it is no longer in the best interest of its
stockholders to continue operations, the ability of the Company to fund an
orderly disposition of assets, pay off its then outstanding liabilities and
return any remaining cash to its shareholders will be limited by the amount of
working capital on hand.
During 1998, the Company's Board of Directors retained an investment
banking firm to introduce Vaxcel and its technology licenses to the trade with
the purpose of concluding strategic transactions for the benefit of the Vaxcel
stockholders. Based on the results of the investment banking firm's efforts and
management's reevaluation of Vaxcel's business strategy, in the fourth quarter
of 1998 the Company adopted a plan to dispose of its primary research and
development activities and intends to complete the plan during 1999.
In January 1999, the Company entered into an agreement with a third
party giving the third party the option to purchase the rights to certain of its
technologies for an aggregate purchase price of $600,000. The third party paid a
nonrefundable option fee of $200,000, with an additional $400,000 due upon the
exercise of the option. See Note 5 to Financial Statements.
In April 1998, December 1998 and January 1999, Vaxcel borrowed a
cumulative total of $181,000 from CytRx pursuant to three convertible note
agreements, $25,000 of which was repaid in February 1999 (see Note 9 to
Financial
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Statements). Such notes bear interest at 9% per annum and are convertible, at
CytRx's discretion, into shares of Vaxcel common stock.
During 1997 and 1998, the Company has received federal government
funding for certain research and development activities via several Small
Business Innovative Research (SBIR) grants, which has offset a significant
portion of the Company's research and development expenditures. Amounts received
totaled $97,000 and $167,000 in 1997 and 1998, respectively.
At December 31, 1998, the Company had net operating loss carryforwards
for income tax purposes of approximately $11.8 million, which will expire in
2008 through 2018, if not utilized. The Company also has research and
development credits available to reduce income taxes, if any, of approximately
$111,000 which will expire in 2008 through 2011, if not utilized. Based on an
assessment of all available evidence including, but not limited to, the
Company's limited operating history and lack of profitability, uncertainties of
the commercial viability of the Company's technology, the impact of government
regulation and healthcare reform initiatives, and other risks normally
associated with biotechnology companies, the Company has concluded that it is
more likely than not that these net operating loss carryforwards and credits
will not be realized and, as a result, a 100% deferred tax valuation allowance
has been recorded against these assets. Such valuation allowance had no impact
on reported net losses. See Note 8 to Financial Statements.
Results of Operations
The Company recorded net losses of $4,993,000 for the year ended
December 31, 1998 as compared to $2,599,000 for 1997 and $1,124,000 for 1996.
The 1998 net loss included a charge of $3,213,000 related to the impairment of
certain intangible assets (see discussion below). The 1997 net loss included a
charge of $951,000 for acquired incomplete research and development incurred
during 1997 as a result of the Company's merger with Zynaxis (see Note 4 to
Financial Statements).
During 1998, 1997 and 1996, Vaxcel recorded collaborative and grant
revenues of $167,000, $243,000 and $78,000, respectively. These amounts relate
to primarily to research funding pursuant to SBIR grants to Vaxcel from the
National Institutes of Health and vary according to the number of grants and
scope of work being conducted during each period. As of December 31, 1998,
Vaxcel did not have any active grants. The costs associated with these
arrangements approximate the revenues recorded and are reflected in research and
development expense.
Research and development expenditures for year ended December 31, 1998
were $916,000, as compared to $1,165,000 for 1997 and $853,000 for 1996. The
acquisition of in-process research and development from Zynaxis did not
significantly impact the Company's ongoing research and development expenditures
during 1997 or 1998, however the Company anticipates significant future
expenditures will be required to continue development of these technologies into
conmercially viable products. Such expenditures have been and will be limited by
the Company's available capital resources. The increase in research and
development expense from 1996 to 1997 is primarily due to higher expenses
associated with the Company's collaborative and grant arrangements, which were
offset by collaborative and grant revenues. Other fluctuations in expenditures
from year to year are due to the timing and nature of external studies being
performed. During 1997 and 1998, in order to conserve cash resources, the
Company took steps to reduce its research and development expenditures which
were not supported by government funding, including personnel reductions.
General and administrative expenses for the year ended December 31,
1998 were $1,119,000, as compared to $772,000 during 1997 and $407,000 during
1996. The overall increase during the three year period is primarily due to
non-transaction expenses associated with the Company's acquisition of Zynaxis in
May 1997 and activities for administration of the combined companies.
Furthermore, during 1998 the Company incurred additional expenses related to (a)
its efforts to secure a strategic transaction, (b) the in-license of certain
technology from the University College London, and (c) certain minimum royalty
obligations to Southern Research Institute. Management believes that inflation
had no material impact on the Company's operations during the three year period
ended December 31, 1998.
In its efforts to raise additional capital, the Company has been
soliciting bids for the sublicense or purchase of the Company's acquired
developed technology, either together with or separately from the Company's
other technologies. In connection with this effort, the Company performed an
evaluation to determine, in accordance with Financial Accounting Standards Board
Statement No. 121, Accounting for the Impairment of Long-Lived Assets and
Long-Lived Assets to Be Disposed Of ("Statement 121"), whether future cash flows
(undiscounted and without interest charges) expected to result
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from the use and eventual disposition of the acquired developed technology would
be less than its aggregate carrying amount and an allocation of goodwill
resulting from the Zynaxis merger. Statement 121 requires that when a group of
assets being tested for impairment was acquired as part of a business
combination accounted for using the purchase method of accounting, any goodwill
that arose as part of the transaction must be included as part of the asset
grouping. As a result of the evaluation, management determined that the
estimated future cash flows expected to be generated by the acquired developed
technology would be less than its carrying amount and allocated goodwill, and
therefore the asset is impaired as defined by Statement 121. Consequently, the
original cost basis of the acquired developed technology and allocated goodwill
were reduced to reflect the fair market value at the date the decision was made,
resulting in a $3,213,000 impairment loss. In determining the fair market value
of the asset, the Company considered the recent transaction as described in Note
5 to Financial Statements.
Interest expense incurred during 1998 relates to the convertible notes
issued to CytRx and includes a $60,000 charge for the beneficial conversion
feature of a portion of the notes.
Year 2000 Issue
The term "Year 2000 issue" is a general term used to describe the
various problems that may result from the improper processing of dates and
date-sensitive calculations by computers and other machinery as the year 2000 is
approached and reached. These problems generally arise from the fact that most
of the world's computer hardware and software have historically used only two
digits to identify the year in a date, often meaning that the computer will fail
to distinguish dates in the "2000's" from dates in the "1900's." These problems
may also arise from other sources as well, such as the use of special codes and
conventions in software that make use of the date field.
State of Readiness
Substantially all of the Company's business systems and services are
provided by CytRx Corporation. CytRx has developed and is implementing a
comprehensive plan (the "Year 2000 Plan") to become Year 2000 ready by the
middle of the fourth quarter 1999. The Year 2000 Plan addresses the following
systems for both CytRx and Vaxcel (collectively, the "Systems"):
- the Company's business-critical information technology and
operating systems ("Critical IT Systems") which are comprised
substantially of commercial off-the-shelf software and other
third party software and hardware relating primarily to
financial operations and reporting, including accounts
payable,
- the Company's non-critical information technology and
operating systems ("Non-Critical IT Systems") which also are
substantially comprised of commercial off-the-shelf software
and other third party software and hardware relating to, among
others, spreadsheet, word processing, and supporting and
related operating systems;
- the systems of the Company's major vendors and other material
service providers ("Third Party Systems"); and
- the Company's non-information technology systems, including
embedded technology ("Non-IT Systems") relating to, among
others, security systems and HVAC.
The Year 2000 Plan consists of four phases: (i) awareness, (ii)
assessment, (iii) remediation, and (iv) creation of contingency plans in the
event of year 2000 failures. CytRx has completed the awareness and assessment
phases of its Year 2000 Plan for all of its Systems, and is well under way
toward completing the remediation phase. As part of the assessment phase, CytRx
has polled substantially all of the third parties who provide material services
to Vaxcel regarding each third party's Year 2000 compliance plan and state of
readiness. CytRx has received responses regarding Year 2000 compliance from most
of such third parties, all of whom have assured the Company that their hardware
and/or software is or will be Year 2000 compliant. CytRx is actively seeking
responses from the remainder of such third parties.
Costs
To date, the Company has not incurred significant costs in connection
with the implementation of its Year 2000 Plan. The Company expects that future
costs, which may include, among other things, the engagement of outside
9
<PAGE> 10
consultants, upgrades or replacements of hardware and software, and
implementation of viable contingency plans, will be borne by CytRx.
Risks and Contingency Plans
The failure to remediate a material Year 2000 problem or develop and
implement a viable contingency plan could result in an interruption in, or a
failure of, certain normal business activities or operations. Such failures
could materially and adversely affect the Company's business, financial
condition and results of operations. Due to the general uncertainty inherent in
the Year 2000 issue, the Company is currently unable to determine the most
reasonably likely worst case Year 2000 scenarios or whether the Year 2000 issue
will have a material impact on the Company. The Company is creating contingency
plans intended to address perceived risks.
ITEM 7A. QUALITATIVE AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISK
N/A
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
10
<PAGE> 11
BALANCE SHEETS
- --------------
Vaxcel, Inc.
<TABLE>
<CAPTION>
December 31,
-------------------------------
1998 1997
------------ ------------
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $ 2,900 $ 690,636
Accounts receivable 5,808 141,898
Note receivable 300,000 -
Other 5,308 500
------------ ------------
Total current assets 314,016 833,034
Property and equipment:
Equipment and furnishings 145,264 299,172
Accumulated depreciation (138,667) (225,017)
------------ ------------
Net property and equipment 6,597 74,155
Other assets:
Notes receivable - 400,000
Acquired developed technology and other intangibles, net 600,000 4,095,347
Other 55,674 55,674
------------ ------------
Total other assets 655,674 4,551,021
------------ ------------
Total assets $ 976,287 $ 5,458,210
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 221,885 $ 20,166
Accrued liabilities 214,483 72,880
Amounts due to affiliates 181,758 73,714
------------ ------------
Total current liabilities 618,126 166,760
Commitments
Stockholders' equity:
Preferred stock ($.001 par value, 2,000,000 shares
authorized; no shares issued and outstanding) -- --
Common stock ($.001 par value, 30,000,000 shares authorized; 10,994,656 and
11,001,070 shares issued and outstanding at December 31, 1998 and 1997,
respectively) 10,995 11,001
Additional paid-in capital 12,485,767 12,425,761
Accumulated deficit (12,138,601) (7,145,312)
------------ ------------
Total stockholders' equity 358,161 5,291,450
------------ ------------
Total liabilities and stockholders' equity $ 976,287 $ 5,458,210
============ ============
</TABLE>
See accompanying notes.
11
<PAGE> 12
STATEMENTS OF OPERATIONS
- ------------------------
Vaxcel, Inc.
<TABLE>
<CAPTION>
Year Ended December 31,
------------------------------------------------
1998 1997 1996
------------ ----------- -----------
<S> <C> <C> <C>
Revenues:
Collaborative and grant revenue $ 166,882 $ 242,961 $ 78,435
License fees 75,000 - 50,000
Investment income 12,589 45,543 7,128
------------ ----------- -----------
254,471 288,504 135,563
Expenses:
Research and development
Transactions with affiliates 22,261 291,806 73,163
Other 894,105 872,959 779,686
Acquired incomplete research and development - 951,017 -
Selling, general and administrative
Transactions with affiliates 150,000 90,000 70,263
Other 901,993 680,599 336,634
Impairment loss 3,212,615 - -
Interest expense 66,786 1,421 -
------------ ----------- -----------
5,247,760 2,887,802 1,259,746
------------ ----------- -----------
Net loss $ (4,993,289) $(2,599,298) $(1,124,183)
============ =========== ===========
Basic and diluted loss per common share $ (0.45) $ (0.26) $ (0.14)
============ =========== ===========
Basic and diluted weighted average shares outstanding 10,996,905 9,939,680 8,104,782
</TABLE>
See accompanying notes.
12
<PAGE> 13
STATEMENTS OF STOCKHOLDERS' EQUITY
- ----------------------------------
Vaxcel, Inc.
<TABLE>
<CAPTION>
Common Stock
------------------------------ Additional
Shares Paid-in Accumulated
Outstanding Amount Capital Deficit Total
-------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
Balance at December 31, 1995 8,000,000 $ 8,000 $ 3,998,000 $ (3,421,831) $ 584,169
Issuance of common stock to CytRx 250,004 250 374,756 375,006
Capital contribution by CytRx 324,994 324,994
Net loss - - - (1,124,183) (1,124,183)
-------------------------------------------------------------------------------
Balance at December 31, 1996 8,250,004 8,250 4,697,750 (4,546,014) 159,986
Issuance of common stock 5,333 5 8,000 8,005
Pre-merger capital contribution by CytRx 163,396 163,396
Issuance of common stock in connection
with merger, net of transaction costs 2,745,733 2,746 7,556,615 7,559,361
Net loss (2,599,298) (2,599,298)
-------------------------------------------------------------------------------
Balance at December 31, 1997 11,001,070 11,001 12,425,761 (7,145,312) 5,291,450
Retirement of common shares (6,414) (6) 6 -
Beneficial conversion feature of
convertible notes 60,000 60,000
Net loss (4,993,289) (4,993,289)
-------------------------------------------------------------------------------
Balance at December 31, 1998 10,994,656 $ 10,995 $ 12,485,767 $ (12,138,601) $ 358,161
========== ========= ============ ============= ===========
</TABLE>
See accompanying notes.
13
<PAGE> 14
STATEMENTS OF CASH FLOWS
- ------------------------
Vaxcel, Inc.
<TABLE>
<CAPTION>
Year Ended December 31,
-----------------------------------------------
1998 1997 1996
----------- ----------- -----------
<S> <C> <C> <C>
Cash flows from operating activities:
Net loss $(4,993,289) $(2,599,298) $(1,124,183)
Adjustments to reconcile net loss to
net cash used in operating activities:
Loss on disposal of fixed assets 44,755 - -
Depreciation 10,902 55,392 51,600
Amortization 282,732 145,644 -
Impairment loss 3,212,615 - -
Charge for beneficial conversion feature of convertible notes 60,000
Charge for acquired incomplete research and development - 951,017 -
Changes in assets and liabilities:
Receivables 136,090 201,384 (44,184)
Other assets 95,192 112,939 (111,674)
Accounts payable 201,719 (57,873) (29,347)
Amounts due to affiliates (48,754) 43,287 16,010
Other liabilities 141,603 (176,759) 113,644
----------- ----------- -----------
Total adjustments 4,136,854 1,275,031 (3,951)
----------- ----------- -----------
Net cash used in operating activities (856,435) (1,324,267) (1,128,134)
Cash flows from investing activities:
Capital expenditures/retirements, net 11,901 (3,371) (2,907)
----------- ----------- -----------
Net cash provided by (used in) investing activities 11,901 (3,371) (2,907)
Cash flows from financing activities:
Proceeds from issuance of convertible notes 156,798 - -
Equity contributions by CytRx - 163,396 324,994
Net proceeds from issuance of common stock to CytRx in connection with
acquisition of Zynaxis, Inc.
- 1,762,392 -
Proceeds from sale of common stock - 8,005 375,006
----------- ----------- -----------
Net cash provided by financing activities 156,798 1,933,793 700,000
----------- ----------- -----------
Net (decrease) increase in cash and cash equivalents (687,736) 606,155 (431,041)
Cash and cash equivalents at beginning of period 690,636 84,481 515,522
----------- ----------- -----------
Cash and cash equivalents at end of period $ 2,900 $ 690,636 $ 84,481
=========== =========== ===========
</TABLE>
See accompanying notes.
14
<PAGE> 15
Notes to Financial Statements
- -----------------------------
Vaxcel, Inc.
1. DESCRIPTION OF BUSINESS AND SIGNIFICANT UNCERTAINTIES
Vaxcel, Inc. ("Vaxcel" or the "Company") was formed on January 6, 1993
as a wholly-owned subsidiary of CytRx Corporation ("CytRx"). In May 1997, Vaxcel
completed a merger with Zynaxis, Inc. ("Zynaxis"), resulting in the issuance of
an aggregate of 12.5% of its outstanding (post-merger) shares of common stock to
the former shareholders of Zynaxis (see Note 3). Vaxcel is engaged in the
development and commercialization of vaccine adjuvants and delivery systems and
a novel vaccine for the treatment of cancer. Vaxcel's business strategy is to
sublicense these adjuvant and delivery system technologies on a
vaccine-by-vaccine basis to companies engaged in vaccine development. However,
as discussed below, there is substantial doubt about the Company's ability to
survive as a going concern.
At December 31, 1998, the Company had cash and cash equivalents of
$3,000 and a working capital deficit of $304,000. The Company has obtained loans
from CytRx pursuant to certain convertible notes (see Note 9) and has received
additional payments subsequent to year-end pursuant to a certain option
agreement (see Note 5). However, the Company's current cash resources, together
with the proceeds of these transactions are not sufficient to fund its
operations beyond the second quarter of 1999. The Company has severely reduced
its operations, limiting its ability to advance its technologies under
development. For the Company to continue as a going concern, it may need to
obtain funds through arrangements that require it to relinquish rights to
certain or all of its technologies. The Company may be required to totally cease
operations and liquidate remaining assets, if any. Should the Company determine
that it is no longer in the best interest of its stockholders to continue
operations, the ability of the Company to fund an orderly disposition of assets,
pay off its then outstanding liabilities and return any remaining cash to its
stockholders will be limited by the amount of working capital on hand.
During 1998, the Company's Board of Directors retained an investment
banking firm to introduce Vaxcel and its technology licenses to the trade with
the purpose of concluding strategic transactions for the benefit of the Vaxcel
stockholders. Based on the results of the investment banking firm's efforts and
management's reevaluation of Vaxcel's business strategy, in the fourth quarter
of 1998 the Company adopted a plan to dispose of its primary research and
development activities and intends to complete the plan during 1999.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Cash Equivalents - The Company considers all highly liquid debt
instruments with an original maturity of 90 days or less to be cash equivalents.
Cash equivalents consist primarily of commercial paper and amounts invested in
money market accounts.
Short-term Investments - Management determines the appropriate
classification of debt securities at the time of purchase and reevaluates such
designation as of each balance sheet date. Debt securities are classified as
held-to-maturity when the Company has the positive intent and ability to hold
the securities to maturity. Held-to-maturity securities are stated at amortized
cost. At December 31, 1997, the Company classified corporate debt securities of
$496,000 as held-to-maturity securities and included such investments in cash
and cash equivalents as their original maturity dates were less than 90 days. At
December 31, 1998, the Company did not hold any debt securities.
Property and Equipment - Property and equipment are stated at cost and
depreciated using the straight-line method based on the estimated useful lives
(generally five years) of the related assets.
Acquired Developed Technology and Other Intangibles -- Acquired
developed technology and other intangible assets, primarily goodwill (See Note
3), are amortized over their estimated useful lives (fifteen years) on a
straight-line basis. Management periodically evaluates the realizability of
recorded acquired developed technology and other intangible assets to determine
whether their carrying values have been impaired. In accordance with Financial
Accounting Standards Board ("FASB") Statement No. 121, Accounting for the
Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of, the
Company records impairment losses on long-lived assets (including goodwill) used
in operations when events and circumstances indicate that the assets might be
impaired and the undiscounted cash flows estimated to be generated by those
assets are less than the carrying amounts of those assets. Any impairment loss
is measured by
15
<PAGE> 16
comparing the fair value of the asset to its carrying amount. As more fully
discussed in Note 4, management has evaluated these assets at December 31, 1998
and has recorded a provision for impairment of such assets.
Patents and Patent Application Costs - Although the Company believes
that its patents and underlying technology have continuing value, the amount of
future benefits to be derived therefrom is uncertain. Patent costs are therefore
expensed rather than capitalized.
Fair Value of Financial Instruments - The carrying amounts reported in
the balance sheet for cash and cash equivalents, accounts and notes receivable,
accounts payable and convertible notes approximate their fair values.
Basic and Diluted Loss per Common Share - Basic and diluted loss per
share are computed based on the weighted average number of common shares
outstanding. Common share equivalents are excluded from the computation of
diluted loss per share since the effect would be antidilutive.
Shares Reserved for Future Issuance - The Company has reserved
approximately 1,500,000 of its authorized but unissued shares of common stock
for future issuance pursuant to stock options and warrants.
Revenue Recognition - Revenues from collaborative research arrangements
and grants are generally recorded as the related costs are incurred. The costs
incurred under such arrangements approximated the revenues reported in the
accompanying statements of operations. License fees reported in the accompanying
statements of operations consist entirely of nonrefundable fees received upon
the signing of certain technology license and option agreements. These fees were
recognized as income when they were received. Such agreements generally contain
provisions for additional fees upon the achievement of certain development
milestones by the licensee and upon approval of the related products, followed
by a royalty based upon net sales. Such fees, if any, will be recognized as
income when they become receivable under the terms of the related contracts.
Stock-Based Compensation - The Company grants stock options for a fixed
number of shares to key employees, directors and consultants with an exercise
price equal to the fair market value of the shares at the date of grant. The
Company accounts for stock option grants in accordance with APB Opinion No. 25,
Accounting for Stock Issued to Employees ("APB 25"), and, accordingly,
recognizes no compensation expense for the stock option grants for which the
terms are fixed. For stock option grants which vest based on certain corporate
performance criteria, compensation expense is recognized to the extent that the
quoted market price per share exceeds the exercise price on the date such
criteria are achieved or are probable.
In October 1995, the FASB issued Statement of Financial Accounting
Standards No. 123, Accounting for Stock-based Compensation ("Statement 123"),
which provides an alternative to APB 25 in accounting for stock-based
compensation issued to employees. However, the Company has continued to account
for stock-based compensation in accordance with APB 25.
Concentrations of Credit Risk - Financial instruments that potentially
subject the Company to significant concentrations of credit risk consist
principally of cash equivalents. The Company maintains cash equivalents in large
well-capitalized financial institutions, and the Company's investment policy
disallows investment in any debt securities rated less than "investment-grade"
by national ratings services.
Use of Estimates - The preparation of the financial statements in
conformity with generally accepted accounting principles requires management to
make estimates and assumptions that affect the amounts reported in the financial
statements and accompanying notes. Actual results could differ from those
estimates.
3. ACQUISITION OF ZYNAXIS, INC.
In December 1996 CytRx, Vaxcel and Zynaxis signed an agreement whereby
Zynaxis would be merged with a wholly-owned subsidiary of Vaxcel. At that time
Zynaxis was a publicly-held biotechnology company engaged in the development of
certain vaccine technologies. The transaction was approved by the Zynaxis
stockholders at a meeting held on May 21, 1997 and was consummated as of that
date.
16
<PAGE> 17
Under the terms of the agreement all of the outstanding shares of
Zynaxis were converted into shares of Vaxcel based upon certain exchange ratios
defined in the agreement, resulting in the issuance of an aggregate of 1.4
million (12.5%) of the outstanding (post-merger) shares of Vaxcel common stock
(at $2.91 per share) to former Zynaxis stockholders at the date of closing. The
merger was treated as a purchase by Vaxcel and constituted a tax-free
reorganization for Zynaxis stockholders. The results of operations of Zynaxis
are included in the Statement of Operations since May 21, 1997.
Pursuant to the agreement, CytRx was to provide up to $2 million to
Zynaxis under a secured credit facility during the period prior to closing of
the merger, at which time the outstanding principal and interest was to be
contributed to the capital of Vaxcel, together with additional equity in the
amount of $4 million less the outstanding principal and interest of the secured
note. At the time of closing the outstanding principal and interest of the
secured note to Zynaxis was approximately $1.7 million, resulting in a net cash
infusion from CytRx to Vaxcel of approximately $2.3 million. In addition, at the
date of closing, Vaxcel issued to CytRx a one-year warrant entitling CytRx to
purchase a number of shares of Vaxcel common stock equal to the amount of
capital which may be necessary for Vaxcel to satisfy requirements for inclusion
in the Nasdaq SmallCap Market, divided by one-half of the $2.91 per share
transaction price at the date of closing. The warrant expired unexercised.
In accordance with the provisions of APB Nos. 16 and 17, all
identifiable assets acquired, including identified intangible assets and
liabilities assumed, were assigned a portion of the purchase price based on
their respective fair values. The fair values of the acquired developed
technology and incomplete research and development were determined based on an
independent appraisal. A summary of the allocation of the purchase price is as
follows (in thousands):
<TABLE>
<S> <C>
Net tangible assets, less outstanding liabilities $ (830)
Acquired developed technology 3,600
Goodwill 641
Acquired incomplete research and development 951
-------
$ 4,362
=======
</TABLE>
4. IMPAIRMENT LOSS
In its efforts to raise additional capital, the Company has been
soliciting bids for the sublicense or purchase of the Company's acquired
developed technology, either together with or separately from the Company's
other technologies. During the fourth quarter, the results of an investment
firm's efforts to dispose of Vaxcel's technologies indicated to management that
the acquired developed technology might be impaired. As a result of this
indication, the Company performed an evaluation to determine, in accordance with
Statement 121, whether future cash flows (undiscounted and without interest
charges) expected to result from the use and eventual disposition of the
acquired developed technology would be less than its aggregate carrying amount
and an allocation of goodwill resulting from the Zynaxis merger. Statement 121
requires that when a group of assets being tested for impairment was acquired as
part of a business combination accounted for using the purchase method of
accounting, any goodwill that arose as part of the transaction must be included
as part of the asset grouping. As a result of the evaluation, management
determined that the estimated future cash flows expected to be generated by the
acquired developed technology would be less than its carrying amount and
allocated goodwill, and therefore the asset is impaired as defined by Statement
121. Consequently, the original cost basis of the acquired developed technology
and allocated goodwill were reduced to reflect the fair market value at the date
the decision was made, resulting in a $3,213,000 impairment loss. In determining
the fair market value of the asset, the Company considered the transaction
described in Note 5, among other factors.
5. POTENTIAL SALE OF TECHNOLOGY
In January 1999, the Company entered into an agreement with a third
party giving the third party the option to purchase the rights to certain of its
technologies for an aggregate purchase price of $600,000. The third party paid a
nonrefundable option fee of $200,000, with an additional $400,000 due upon the
exercise of the option. The initial option period expires on March 22, 1999,
subject to extension upon the payment of additional fees by the third party.
17
<PAGE> 18
6. COMMITMENTS
Rental expense under operating leases during the years ended December
31, 1998, 1997 and 1996 approximated $96,000, $61,000, and $56,000,
respectively. Minimum annual future obligations for operating leases are
approximately $7,500, $4,100 and $2,400 for 1999, 2000 and 2001, respectively.
At December 31, 1998, pursuant to a license agreement for certain of
its technologies, the Company is subject to minimum annual payments of $190,000,
$120,000 and $140,000 during the years 1999, 2000 and 2001. In the years 2002
and beyond, the annual minimum payments increase by $10,000 per year, until the
expiration of the applicable patents.
7. STOCK OPTIONS AND WARRANTS
The Company has stock option plans pursuant to which key employees,
directors and consultants of the Company are eligible to receive incentive
and/or non-qualified options to purchase shares of the Company's common stock.
The options granted under the Plan have lives of ten years from the dates of
grant and generally become exercisable over a three year period from the dates
of grant, with the exception of certain options granted to the Company's Chief
Executive Officer and its Vice President of Research and Development, which are
subject to vesting criteria based upon corporate performance objectives.
Exercise prices are set at the fair market values of the common stock on the
dates of grant. No compensation expense was recorded in the three years ended
December 31, 1998.
A summary of the Company's stock option activity, and related
information for the three years ended December 31, 1998 is as follows:
<TABLE>
<CAPTION>
Options Weighted Average Exercise Price
---------------------------------------- -------------------------------
1998 1997 1996 1998 1997 1996
---- ---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C> <C>
Outstanding - beginning of year 847,000 794,453 735,000 $1.63 $1.50 $1.50
Granted 510,000 63,000 73,620 .63 3.18 1.50
Exercised - (5,333) - - 1.50 -
Forfeited (281,500) (5,120) (14,167) 1.73 1.50 1.50
---------- -------- --------
Outstanding - end of year 1,075,500 847,000 794,453 $1.12 $1.63 $1.50
========== ======== ========
Exercisable at end of year 160,661 293,663 184,332 $1.68 $1.57 $1.50
Weighted average fair value of
options granted during the year $ .42 $ 1.82 $ 0.83
</TABLE>
The exercise prices for options outstanding as of December 31, 1998
ranged from $.63 to $3.25. The weighted average remaining contractual life of
those options is 6.2 years.
The Company has elected to follow APB 25 and related interpretations in
accounting for its employee stock options because, as discussed below, the
alternative fair value accounting provided for under Statement 123 requires use
of option valuation models that were not developed for use in valuing employee
stock options.
Pro forma information regarding net loss and loss per share is required
by Statement 123, which also requires that the information be determined as if
the Company has accounted for its employee stock options granted subsequent to
December 31, 1994 under the fair value method of that Statement. The fair value
for these options was estimated at the date of grant using a Black-Scholes
option pricing model with the following assumptions: weighted-average risk-free
interest rates of 5.83% for 1998, 6.53% for 1997 and 6.34% for 1996; dividend
yields of 0.0%; volatility factors of the expected market price of the Company's
common stock of .563 for 1998, .585 for 1997 and .378 for 1996; and a weighted
average expected life of the option of 8 years.
The Black-Scholes option valuation model was developed for use in
estimating the fair value of traded options which have no vesting restrictions
and are fully transferable. In addition, option valuation models require the
input of highly subjective assumptions including the expected stock price
volatility. Because the Company's employee stock options have characteristics
significantly different from those of traded options, and because changes in the
subjective input
18
<PAGE> 19
assumptions can materially affect the fair value estimate, in management's
opinion, the existing models do not necessarily provide a reliable single
measure of the fair value of its employee stock options.
For purposes of pro forma disclosures, the estimated fair value of the
options is amortized to expense over the options' vesting periods. The Company's
pro forma information is as follows:
<TABLE>
<CAPTION>
1998 1997 1996
---- ---- ----
<S> <C> <C> <C>
Pro forma net loss ($5,073,748) ($2,692,650) ($1,182,382)
Pro forma net loss per share (basic and diluted) ($.46) ($.27) ($.15)
</TABLE>
8. INCOME TAXES
The Company has not incurred or paid income taxes since its inception.
For income tax purposes, as of December 31, 1998 the Company has an aggregate of
approximately $11,810,000 of net operating losses available to offset against
future taxable income, subject to certain limitations. Included in this amount
is $3,360,000 of net operating losses generated by Zynaxis prior to the merger.
See discussion below. Such losses expire in 2008 through 2018. The Company also
has an aggregate of approximately $111,000 of research and development credits
available for offset against future income taxes which expire in 2008 through
2012.
Deferred income taxes reflect the net effect of temporary differences
between the financial reporting carrying amounts of assets and liabilities and
income tax carrying amounts of assets and liabilities. The components of the
Company's deferred tax assets and liabilities are as follows:
<TABLE>
<CAPTION>
December 31,
-----------------------------
1998 1997
----------- -----------
<S> <C> <C>
Deferred tax assets:
Net operating loss carryforward $ 4,488,000 $ 3,566,000
Tax credit carryforward 111,000 77,000
Other 1,175,000 1,179,000
----------- -----------
Total deferred tax assets 5,774,000 4,822,000
Deferred tax liabilities:
Acquired developed technology and other
intangibles (228,000) (1,556,000)
Depreciation - (16,000)
----------- -----------
Total deferred tax liabilities (228,000) (1,572,000)
----------- -----------
Net deferred tax assets 5,546,000 3,250,000
Valuation allowance (5,546,000) (3,250,000)
----------- -----------
$ - $ -
=========== ===========
</TABLE>
Based on assessments of all available evidence as of these dates,
management has concluded that the respective deferred income tax assets should
be reduced by valuation allowances equal to the amounts of the net deferred
income tax assets.
The total amount of net operating loss carryforwards generated by
Zynaxis prior to the merger was $31,000,000. The use of pre-acquisition
operating loss carryforwards is subject to limitations imposed by the Internal
Revenue Code. The Company anticipates that these limitations will affect
utilization of the carryforwards prior to expiration. Therefore, for financial
reporting purposes the Company has recorded a deferred tax asset of $1,277,000,
related only to $3,360,000 of net operating losses not anticipated to be
affected by these limitations. A corresponding valuation allowance of $1,277,000
has been recorded. When realized, the tax benefit of these loss carryforwards
will be applied to reduce acquired developed technology and other intangibles
related to the acquisition of Zynaxis.
19
<PAGE> 20
9. RELATED PARTY TRANSACTIONS
LICENSE AGREEMENT
At inception, the Company licensed from CytRx exclusive rights to
certain biologically-active copolymers used in Vaxcel's novel vaccine
formulations. Royalties paid to CytRx pursuant to this agreement amounted to
$7,500 during the year ended December 31, 1996. No royalties were paid to CytRx
during 1997 or 1998.
SUPPLY AGREEMENT
During the term of the related license agreement, CytRx agreed to
supply the Company with certain copolymers required in the manufacture and
development of the vaccine delivery formulation. Amounts paid to CytRx for
production of copolymers were $5,000, $80,000 and $11,000 during the years ended
December 31, 1998, 1997 and 1996, respectively.
SERVICES AND FACILITIES AGREEMENTS
The Company entered into service and facilities agreements with CytRx
and a wholly-owned subsidiary of CytRx, whereby CytRx and its subsidiary have
provided the Company with office and laboratory space, certain administrative
and laboratory services and the services of certain CytRx executives. Pursuant
to these agreements, the Company expensed a total of $96,000, $138,000 and
$121,000 during the years ended December 31, 1998, 1997 and 1996, respectively.
Management believes that the methods used in allocating these costs are
reasonable and that such charges approximate the fair value of the space and
services provided which would have been incurred on a stand alone basis.
During 1998 and 1997, Vaxcel contracted with the above-mentioned
subsidiary of CytRx, which was divested by CytRx in February 1998, for certain
analytical services. Amounts expensed in 1998 and 1997 pursuant to these
contracts were $11,000 and $164,000, respectively.
CONVERTIBLE NOTES
In March 1998, Vaxcel borrowed $100,000 from CytRx pursuant to a
convertible note agreement (the "March 1998 Note"). The March 1998 Note bears
interest at 9% per annum and was due and payable on December 31, 1998. On
December 31, 1998, CytRx granted Vaxcel an extension of the due date until March
31, 1999. The March 1998 Note is convertible into shares of Vaxcel common stock
at the lower of (a) $.3125 per share, or (b) the average closing bid price of
Vaxcel's common stock for the 5 days preceding conversion. Such beneficial
conversion feature was determined to have a fair value of $60,000 at the date of
issuance and was recorded as interest expense at the date of issuance since the
March 1998 Note was immediately convertible.
In December 1998, Vaxcel borrowed $56,000 from CytRx pursuant to a
convertible note agreement (the "December 1998 Note"). The December 1998 Note
bears interest at 9% per annum and is due and payable on March 31, 1999. The
December 1998 Note is convertible into shares of Vaxcel common stock at the
lower of (a) $.0625 per share, or (b) the average closing bid price of Vaxcel's
common stock for the 5 days preceding conversion. The December 1998 Note is
collateralized by any proceeds received in connection with a certain technology
license agreement.
In January 1999, Vaxcel borrowed $25,000 from CytRx pursuant to a
convertible note agreement (the "January 1999 Note"). The January 1999 Note
bears interest at 9% per annum and was due and payable on March 31, 1999. The
January 1999 Note was repaid by Vaxcel in February 1999.
Interest paid by Vaxcel to CytRx pursuant to the March 1998 Note and
the December 1998 Note totaled $6,786 during 1998.
20
<PAGE> 21
REPORT OF INDEPENDENT AUDITORS
The Board of Directors
Vaxcel, Inc.
We have audited the accompanying balance sheets of Vaxcel, Inc. as of December
31, 1998 and 1997, and the related statements of operations, stockholders'
equity and cash flows for each of the three years in the period ended December
31, 1998. Our audits also included the financial statement schedule listed in
the Index at Item 14(a). These financial statements and schedule are the
responsibility of the Company's management. Our responsibility is to express an
opinion on these financial statements and schedule based on our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes, examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation. We believe that our
audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of Vaxcel, Inc. at December 31,
1998 and 1997, and the results of its operations and its cash flows for each of
the three years in the period ended December 31, 1998, in conformity with
generally accepted accounting principles. Also, in our opinion, the related
financial statement schedule, when considered in relation to the basic financial
statements taken as a whole, presents fairly in all material respects the
information set forth therein.
As discussed in Note 1 to the financial statements, the Company's recurring
losses from operations and accumulated deficit raise substantial doubt about its
ability to continue as a going concern. Management's plans as to these matters
are also described in Note 1. The 1998 financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
/s/ Ernst & Young LLP
Atlanta, Georgia
March 9, 1999
21
<PAGE> 22
ITEM 9 CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
Information with respect to this item is incorporated herein by
reference from the Proxy Statement, which is expected to be filed pursuant to
Regulation 14A within 120 days after the end of the Company's 1998 fiscal year.
ITEM 11. EXECUTIVE COMPENSATION
Information with respect to this item is incorporated herein by
reference from the Proxy Statement, which is expected to be filed pursuant to
Regulation 14A within 120 days after the end of the Company's 1998 fiscal year.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
Information with respect to this item is incorporated herein by
reference from the Proxy Statement, which is expected to be filed pursuant to
Regulation 14A within 120 days after the end of the Company's 1998 fiscal year.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
License Agreement
Vaxcel derives its rights to develop and commercialize Optivax from a
license agreement with CytRx effective January 1993, as amended (the "Optivax
Agreement"), which grants to Vaxcel the exclusive, worldwide right to develop
and sell certain copolymers covered by claims of certain United States and
foreign patent rights of CytRx, for use to enhance immune response in humans, in
combination with an antigen in a vaccine delivery system (the "Optivax Field").
Expressly excluded from the Optivax Field are use of the copolymers alone as
non-specific immune stimulants and use of the copolymers as therapeutic agents
for infectious diseases. Under the terms of the Optivax Agreement, Vaxcel is
required to pay CytRx a 10% royalty on net sales by Vaxcel or its affiliates of
vaccines directly commercialized by Vaxcel in the Optivax Field for the longer
of ten years from the first commercial sale of the product or the life of any
patent right covering the licensed product. The Optivax Agreement gives Vaxcel
the right to sublicense its rights, subject to certain conditions and the
payment to CytRx of 15% of the sublicense compensation received by Vaxcel.
Royalties paid to CytRx pursuant to the Optivax Agreement amounted to $7,500
during 1996. No royalties were paid pursuant to this agreement during 1997 or
1998.
Supply Agreement
The Optivax Agreement gives Vaxcel the right to make finished vaccines
but does not provide the right to make the bulk copolymers, which are supplied
by CytRx under a supply agreement entered into between Vaxcel and CytRx
effective January 1993 and amended as of October 10, 1997 (the "Supply
Agreement"). Under the terms of the Supply Agreement, CytRx is to provide the
Optivax CRL-1005 copolymer at prices per kilogram which have been predetermined
in the Supply Agreement. If Vaxcel requests CytRx to synthesize and supply a
copolymer different than the Optivax CRL1005 copolymer, CytRx will offer to
supply such copolymers to Vaxcel upon terms similar to the Optivax CRL1005
copolymer if such copolymer is similar in structure and requires similar
manufacturing procedures with similar cost. In the event the cost of CytRx
supplying such copolymers to Vaxcel is not similar to the Optivax CRL1005
copolymer or involves other manufacturing processes, the parties will negotiate
revised prices per kilogram and all other terms of the Supply Agreement will
remain unchanged. Vaxcel's requirements of the copolymers are to be provided
either directly by CytRx or through a third-party supplier selected by CytRx. If
CytRx or its licensed third-party chemical manufacturer is unwilling or unable
to supply the copolymers, then Vaxcel and/or its sublicensees shall have the
right to make or have made the copolymers and CytRx will make appropriate
manufacturing know-how available to Vaxcel or its designee. The Supply Agreement
is subject to termination by CytRx upon a termination event under the Optivax
Agreement and in other customary circumstances (such as a breach by Vaxcel).
Amounts paid to CytRx for production of copolymers were $5,000, $79,591 and
$10,923 during 1998, 1997 and 1996, respectively.
22
<PAGE> 23
Services and Facilities Agreements
Effective June 1, 1993 and amended October 10, 1996, Vaxcel and CytRx
entered into a services and facilities use agreement pursuant to which CytRx
agreed to provide Vaxcel with certain management, administrative, and scientific
services, as well as the use of certain administrative space at the CytRx
facility in Norcross, Georgia. Amounts paid to CytRx pursuant to this agreement
were $90,000, $90,000 and $69,963 during 1998, 1997 and 1996, respectively.
Effective January 1, 1996 and amended October 16, 1996, Vaxcel and Proceutics,
Inc. ("Proceutics"), a then wholly-owned subsidiary of CytRx, entered into a
facilities use agreement whereby Proceutics reserved and made available to
Vaxcel certain laboratory, vivarium and related space at the Proceutics facility
in Norcross, Georgia. Amounts paid to Proceutics pursuant to this agreement were
$6,037, $48,300 and $51,000 during 1998, 1997 and 1996, respectively.
During 1998 and 1997, Vaxcel contracted with Proceutics for certain
analytical laboratory services. Amounts paid to Proceutics in 1998 and 1997
pursuant to these contracts were $11,223 and $163,915, respectively.
Convertible Notes
Effective March 15, 1997, in order to provide necessary funding for
certain expenses and operations of Vaxcel pending the Merger, CytRx and Vaxcel
entered into a Loan Agreement (the "1997 Loan"), pursuant to which CytRx agreed
to lend up to $400,000 to Vaxcel. The purpose of the 1997 Loan was to provide
funding to Vaxcel for certain expenses directly or indirectly related to the
Merger incurred by either CytRx or Vaxcel and for ongoing operational cash needs
prior to the Merger. The 1997 Loan was unsecured and was interest-free until May
1, 1997; thereafter the interest rate was prime plus 2%. The outstanding 1997
Loan balance of $286,067, together with accrued interest of $1,421 was repaid by
Vaxcel upon the closing of its merger with Zynaxis on May 21, 1997.
In March 1998, Vaxcel borrowed $100,000 from CytRx pursuant to a
convertible note agreement (the "March 1998 Note"). The March 1998 Note bears
interest at 9% per annum and was due and payable on December 31, 1998. On
December 31, 1998, CytRx granted Vaxcel an extension of the due date until March
31, 1999. The March 1998 Note is convertible into shares of Vaxcel common stock
at the lower of (a) $.3125 per share, or (b) the average closing bid price of
Vaxcel's common stock for the 5 days preceding conversion.
In December 1998, Vaxcel borrowed $56,000 from CytRx pursuant to a
convertible note agreement (the "December 1998 Note"). The December 1998 Note
bears interest at 9% per annum and is due and payable on March 31, 1999. The
December 1998 Note is convertible into shares of Vaxcel common stock at the
lower of (a) $.0625 per share, or (b) the average closing bid price of Vaxcel's
common stock for the 5 days preceding conversion.
In January 1999, Vaxcel borrowed $25,000 from CytRx pursuant to a
convertible note agreement (the "January 1999 Note"). The January 1999 Note bore
interest at a rate of 9% per annum and was due and payable on March 31, 1999.
The January 1999 Note was repaid by Vaxcel in February 1999.
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K
(a) Documents filed as part of this 10-K:
1. Financial Statements
Balance Sheets as of December 31, 1998 and 1997
Statements of Operations for the Years Ended December 31, 1998, 1997
and 1996
Statements of Stockholders' Equity for the Years Ended December 31,
1996, 1997 and 1998
Statements of Cash Flows for the Years Ended December 31, 1998, 1997
and 1996
23
<PAGE> 24
Notes to Financial Statements
Report of Independent Auditors
2. Financial Statement Schedules:
Schedule II - Valuation and Qualifying Accounts for the years ended
December 31, 1998, 1997 and 1996
All other schedules are omitted because they are not required, not
applicable, or the information is provided in the financial statements or notes
thereto.
3. Exhibits required by Item 601 of Regulation S-K:
See Exhibit Index on page 25 of this Form 10-K.
(b) Reports on Form 8-K:
None
24
<PAGE> 25
Vaxcel, Inc.
Form 10-K Exhibit Index
<TABLE>
<CAPTION>
Exhibit
Number
- -------
<S> <C> <C>
2.1 Agreement and Plan of Merger and Contribution dated as of December 6, 1996,
by and among CytRx Corporation, Vaxcel, Inc., Vaxcel Merger Subsidiary, Inc.
and Zynaxis, Inc. (a)
3.1 Certificate of Incorporation (a)
3.2 By-Laws (a)
10.1 Amended and Restated License Agreement dated October 10, 1996
by and between Vaxcel, Inc. and CytRx Corporation (a)
10.2 Amended and Restated Supply Agreement dated October 10, 1996
by and between Vaxcel, Inc. and CytRx Corporation (a)
10.3 Services and Facilities Use Agreement dated October 10, 1996 by and
between Vaxcel, Inc. and CytRx Corporation (a)
10.4* Vaxcel, Inc. 1993 Stock Option Plan (a)
10.5 Convertible Note dated March 30, 1998 by and between Vaxcel, Inc.
and CytRx Corporation
10.6 Convertible Note dated December 18, 1998 by and between Vaxcel, Inc.
and CytRx Corporation
10.7 Convertible Note dated January 7, 1999 by and between Vaxcel, Inc.
and CytRx Corporation
10.8 Option Agreement dated January 27, 1999 by and between Vaxcel, Inc.
and Innovax Corporation
23.1 Consent of Ernst & Young LLP
27.1 Financial Data Schedule (for SEC use only)
</TABLE>
*Indicates a management contract or compensatory plan or arrangement.
- ----------
(a) Incorporated by reference to the Company's Registration Statement on
Form S-4 (File No. 333-19125) filed on March 26, 1997.
25
<PAGE> 26
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized.
VAXCEL, INC.
By: /s/ Mark J. Newman
-------------------------------
Mark J. Newman, President
Date: March 30, 1999 and Chief Executive Officer
(Principal Executive Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934,
this report has been signed below by the following persons on behalf of the
Registrant and in the capacities and on the dates indicated.
<TABLE>
<CAPTION>
Signature Title Date
- --------- ----- ----
<S> <C> <C>
/s/ Jack L. Bowman Chairman of the March 30, 1999
- -------------------------- Board of Directors
Jack L. Bowman
/s/ Lyle A. Hohnke Director March 30, 1999
- --------------------------
Lyle A. Hohnke
/s/ Jack J. Luchese Director March 30, 1999
- --------------------------
Jack J. Luchese
/s/ Herbert H. McDade, Jr. Director March 30, 1999
- --------------------------
Herbert H. McDade, Jr.
/s/ Mark J. Newman Director March 30, 1999
- --------------------------- President and Chief Executive Officer
Mark J. Newman (Principal Executive Officer)
/s/ Mark W. Reynolds Chief Financial Officer March 30, 1999
- --------------------------- (Principal Financial Officer)
Mark W. Reynolds
</TABLE>
26
<PAGE> 27
VAXCEL, INC.
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS
FOR THE YEARS ENDED DECEMBER 31, 1998, 1997 AND 1996
<TABLE>
<CAPTION>
Additions
--------------------------
Balance at Charged to Charged to Balance at
Beginning Costs and Other End
Description of Period Expenses Accounts Deductions of Period
------------------------------------- ------------ ------------ ---------- ----------- ------------
<S> <C> <C> <C> <C> <C>
Reserve Deducted in the Balance Sheet
from the Asset to Which it Applies:
Allowance for Deferred Tax Assets
Year ended December 31, 1998 $ 3,250,000 $ - $ 2,296,000 $ -- $ 5,546,000
Year ended December 31, 1997 1,776,000 - 1,474,000 -- 3,250,000
Year ended December 31, 1996 1,300,000 - 476,000 -- 1,776,000
</TABLE>
27
<PAGE> 1
EXHIBIT 10.5
CONVERTIBLE NOTE
March 30, 1998 Norcross, Georgia
For value received, Vaxcel, Inc., a Delaware corporation (the
"Borrower"), hereby promises to pay to CytRx Corporation, a Delaware corporation
(the "Lender"), the principal amount as shall have been advanced under this
Convertible Note ("the Note") and shall then be outstanding, together with
interest accrued upon such outstanding balances calculated in accordance with
this Note.
1. The Lender agrees to make loans (the "Loan") to the Borrower from
time to time in aggregate principal amounts not to exceed at any one time
outstanding $100,000 (the "Commitment"). Borrower and Lender agree that the
purpose of the Loan is to provide such funds as necessary for (a) the initial
retainer fee pursuant to the agreement dated February 27, 1998 between Lender,
Borrower and Interstate/Johnson Lane and (b) the upfront license fee required
for the proposed license agreement between Borrower and University College
London for certain a cancer antigen.
2. Interest shall accrue on the outstanding principal balance
hereunder, at a per annum rate of nine percent (9%) and shall be added to the
outstanding principal balance at the end of each month if not sooner paid.
Interest shall be calculated on the basis of a 365-day year for the actual
number of days elapsed.
3. The Borrower may prepay any Loan in whole at any time or in part
from time to time, without premium or penalty. All payments of principal,
interest, fees or other amounts payable hereunder shall be remitted to the
Lender at the address specified by the Lender from time to time by check or as
the Lender shall otherwise direct. Upon payment in full of the principal and
interest on this Note, the Lender will surrender to the Borrower this Note duly
marked canceled.
4. The aggregate outstanding principal balance of the Loan and accrued
interest outstanding thereon shall be due and payable on December 31, 1998, or
such other time as may be agreed to in writing by Lender and Borrower.
5. Lender has the right, at its option, to convert all or any portion
of the outstanding principal and accrued but unpaid interest payable under this
Note into that number of fully paid and non-assessable shares of common stock of
the Borrower ("Common Stock") obtained by dividing the outstanding principal
amount of this Note or portion thereof to be converted by the lower of (a)
$.3125 or (b) the average closing bid price of Borrower's common stock for the 5
days preceding Lender's conversion notice, or if Borrower's common stock has
not traded during at least 3 of the 5 preceeding days, then the average
<PAGE> 2
price shall be determined by reference to the last 3 days on which Borrower's
common stock did trade (the "Conversion Price"), upon surrender of this Note to
the Borrower accompanied by written notice of conversion duly executed and (if
so required by the Borrower) by instruments of transfer, in form satisfactory to
the Borrower, duly executed by the Lender or its duly authorized attorney.
6. No failure or delay on the part of the Lender in exercising any
right, power or remedy under this Note shall operate as a waiver thereof; nor
shall any single or partial exercise of any such right, power or remedy preclude
any other or further exercise thereof or the exercise of any other right, power
or remedy under this Note. The rights and remedies provided under this Note are
cumulative and not exclusive of any remedies provided on by law.
7. No amendment, modification, termination or waiver of this Note or
any provision hereof nor any consent to any departure by the Borrower herefrom
shall be effective unless the same is in writing and signed by the Lender and
then any such waiver or consent shall be effective only in the specific instance
and for the specific purpose for which given. No notice to or demand on the
Borrower shall entitle the Borrower to any other or further notice or demand in
similar or other circumstances.
8. THIS NOTE AND ALL RIGHTS AND OBLIGATIONS OF THE PARTIES HEREUNDER
SHALL BE GOVERNED BY AND CONSTRUED AND ENFORCED IN ACCORDANCE WITH THE LAWS OF
THE STATE OF GEORGIA.
9. This Note shall bind and inure to the benefit of the Borrower and
the Lender and their respective successors and assigns, except the Borrower
shall not have the right to assign or otherwise transfer any of its rights or
any interest of it under this Note without the prior written consent of the
Lender.
10. Any provision of this Note which is prohibited or unenforceable in
any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of
such prohibition or unenforceability without affecting the validity or
enforceability of the remainder of this Note or the enforceability of such
provision in any other jurisdiction.
11. All notices, requests, demands, directions, declarations and other
communications provided for in this Note shall, except as otherwise expressly
provided, be mailed by registered or certified mail, return receipt requested,
or telegraphed, telecopied, or delivered in hand to the applicable party at its
address specified from time to time. The foregoing shall be effective when
deposited in the mails, postage prepaid, addressed as aforesaid and shall
whenever sent by telegram or telecopied or delivered in hand be effective when
received. Any party may change its address by a communication in accordance
herewith.
<PAGE> 3
IN WITNESS WHEREOF, the Borrower and the Lender have caused this Note
to be duly executed as of the day and year first above written.
VAXCEL, INC.
By /s/ Paul J. Wilson
---------------------------------------
Paul J. Wilson
President & Chief Executive Officer
Accepted and agreed to by:
CYTRX CORPORATION
By /s/ Jack J. Luchese
---------------------------------------
Jack J. Luchese
President & Chief Executive Officer
<PAGE> 1
EXHIBIT 10.6
CONVERTIBLE NOTE
December 18, 1998 Norcross, Georgia
For value received, Vaxcel, Inc., a Delaware corporation (the
"Borrower"), hereby promises to pay to CytRx Corporation, a Delaware corporation
(the "Lender"), the principal amount as shall have been advanced under this
Convertible Note ("the Note") and shall then be outstanding, together with
interest accrued upon such outstanding balances calculated in accordance with
this Note.
1. The Lender agrees to make loans (the "Loan") to the Borrower from
time to time in aggregate principal amounts not to exceed at any one time
outstanding $56,000 (the "Commitment"). Borrower and Lender agree that the
purpose of the Loan is to provide such funds as necessary for payment of the
1998 minimum annual payment to Southern Research Institute.
2. Interest shall accrue on the outstanding principal balance
hereunder, at a per annum rate of nine percent (9%) and shall be added to the
outstanding principal balance at the end of each month if not sooner paid.
Interest shall be calculated on the basis of a 365-day year for the actual
number of days elapsed.
3. The Borrower may prepay any Loan in whole at any time or in part
from time to time, without premium or penalty. All payments of principal,
interest, fees or other amounts payable hereunder shall be remitted to the
Lender at the address specified by the Lender from time to time by check or as
the Lender shall otherwise direct. Upon payment in full of the principal and
interest on this Note, the Lender will surrender to the Borrower this Note duly
marked canceled.
4. The aggregate outstanding principal balance of the Loan and accrued
interest outstanding thereon shall be due and payable on March 31, 1999, or such
other time as may be agreed to in writing by Lender and Borrower.
5. The outstanding principal balance of the Loan and accrued interest
outstanding shall be fully collateralized by any proceeds received from the
sale, sublicense, or other disposition of certain rights granted to the
Borrower, or its affiliates, pursuant to its technology license agreement with
Southern Research Institute.
6. Lender has the right, at its option, to convert all or any portion
of the outstanding principal and accrued but unpaid interest payable under this
Note into that number of fully paid and non-assessable shares of common stock of
the Borrower ("Common Stock")
<PAGE> 2
obtained by dividing the outstanding principal amount of this Note or portion
thereof to be converted by the lower of (a) $.0625 or (b) the average closing
bid price of Borrower's common stock for the 5 days preceeding Lender's
conversion notice, or if Borrower's common stock has not traded during at least
3 of the 5 preceeding days, then the average price shall be determined by
reference to the last 3 days on which Borrower's common stock did trade (the
"Conversion Price"), upon surrender of this Note to the Borrower accompanied by
written notice of conversion duly executed and (if so required by the Borrower)
by instruments of transfer, in form satisfactory to the Borrower, duly executed
by the Lender or its duly authorized attorney.
7. No failure or delay on the part of the Lender in exercising any
right, power or remedy under this Note shall operate as a waiver thereof; nor
shall any single or partial exercise of any such right, power or remedy preclude
any other or further exercise thereof or the exercise of any other right, power
or remedy under this Note. The rights and remedies provided under this Note are
cumulative and not exclusive of any remedies provided on by law.
8. No amendment, modification, termination or waiver of this Note or
any provision hereof nor any consent to any departure by the Borrower herefrom
shall be effective unless the same is in writing and signed by the Lender and
then any such waiver or consent shall be effective only in the specific instance
and for the specific purpose for which given. No notice to or demand on the
Borrower shall entitle the Borrower to any other or further notice or demand in
similar or other circumstances.
9. THIS NOTE AND ALL RIGHTS AND OBLIGATIONS OF THE PARTIES HEREUNDER
SHALL BE GOVERNED BY AND CONSTRUED AND ENFORCED IN ACCORDANCE WITH THE LAWS OF
THE STATE OF GEORGIA.
10. This Note shall bind and inure to the benefit of the Borrower and
the Lender and their respective successors and assigns, except the Borrower
shall not have the right to assign or otherwise transfer any of its rights or
any interest of it under this Note without the prior written consent of the
Lender.
11. Any provision of this Note which is prohibited or unenforceable in
any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of
such prohibition or unenforceability without affecting the validity or
enforceability of the remainder of this Note or the enforceability of such
provision in any other jurisdiction.
12. All notices, requests, demands, directions, declarations and other
communications provided for in this Note shall, except as otherwise expressly
provided, be mailed by registered or certified mail, return receipt requested,
or telegraphed, telecopied, or delivered in hand to the applicable party at its
address specified from time to time. The foregoing shall be effective when
deposited in the mails, postage prepaid, addressed as aforesaid and shall
whenever sent by telegram or telecopied or delivered in hand be effective when
received. Any party may change its address by a communication in accordance
herewith.
<PAGE> 3
IN WITNESS WHEREOF, the Borrower and the Lender have caused this Note
to be duly executed as of the day and year first above written.
VAXCEL, INC.
By /s/ Mark J. Newman
-----------------------------------------
Mark J. Newman
President & Chief Executive Officer
Accepted and agreed to by:
CYTRX CORPORATION
By /s/ Jack J. Luchese
-----------------------------------------
Jack J. Luchese
President & Chief Executive Officer
<PAGE> 1
EXHIBIT 10.7
CONVERTIBLE NOTE
January 7, 1999 Norcross, Georgia
For value received, Vaxcel, Inc., a Delaware corporation (the
"Borrower"), hereby promises to pay to CytRx Corporation, a Delaware corporation
(the "Lender"), the principal amount as shall have been advanced under this
Convertible Note ("the Note") and shall then be outstanding, together with
interest accrued upon such outstanding balances calculated in accordance with
this Note.
1. Lender agrees to make loans (the "Loan") to the Borrower from time
to time in aggregate principal amounts not to exceed at any one time outstanding
$25,000 (the "Commitment"). Borrower and Lender agree that the purpose of the
Loan is to provide such funds as necessary for payment of compensation to
Borrower's President & CEO for the period January 1 to February 28, 1999.
2. Lender and Borrower agree that certain amounts currently owed to
Lender by Borrower for certain administrative services, facilities rental,
401(k) matching contributions, and miscellaneous expenses paid by Lender on
behalf of Borrower (eg. Group insurance premiums), as well as future amounts of
such nature, shall be added to the principal balance of this Note.
3. Interest shall accrue on the outstanding principal balance
hereunder, at a per annum rate of nine percent (9%) and shall be added to the
outstanding principal balance at the end of each month if not sooner paid.
Interest shall be calculated on the basis of a 365-day year for the actual
number of days elapsed.
4. The Borrower may prepay any Loan in whole at any time or in part
from time to time, without premium or penalty. All payments of principal,
interest, fees or other amounts payable hereunder shall be remitted to the
Lender at the address specified by the Lender from time to time by check or as
the Lender shall otherwise direct. Upon payment in full of the principal and
interest on this Note, the Lender will surrender to the Borrower this Note duly
marked canceled.
5. The aggregate outstanding principal balance of the Loan and accrued
interest outstanding thereon shall be due and payable on March 31, 1999, or such
other time as may be agreed to in writing by Lender and Borrower.
6. The outstanding principal balance of the Loan and accrued interest
outstanding shall be fully collateralized by any proceeds received from the
sale, sublicense, or other
<PAGE> 2
disposition of any technology rights or other assets currently held by Borrower
or its affiliates, such rights and assets to include, but not be limited to,
certain technology rights granted to Borrower by Southern Research Institute,
certain technology rights granted to Borrower by Lender, and a $300,000 note due
to Borrower by Proclinical, Inc.
7. Lender has the right, at its option, to convert all or any portion
of the outstanding principal and accrued but unpaid interest payable under this
Note into that number of fully paid and non-assessable shares of common stock of
the Borrower ("Common Stock") obtained by dividing the outstanding principal
amount of this Note or portion thereof to be converted by the lower of (a)
$.03125 or (b) the average closing bid price of Borrower's common stock for the
5 days preceeding Lender's conversion notice, or if Borrower's common stock has
not traded during at least 3 of the 5 preceeding days, then the average price
shall be determined by reference to the last 3 days on which Borrower's common
stock did trade (the "Conversion Price"), upon surrender of this Note to the
Borrower accompanied by written notice of conversion duly executed and (if so
required by the Borrower) by instruments of transfer, in form satisfactory to
the Borrower, duly executed by the Lender or its duly authorized attorney.
8. No failure or delay on the part of the Lender in exercising any
right, power or remedy under this Note shall operate as a waiver thereof; nor
shall any single or partial exercise of any such right, power or remedy preclude
any other or further exercise thereof or the exercise of any other right, power
or remedy under this Note. The rights and remedies provided under this Note are
cumulative and not exclusive of any remedies provided on by law.
9. No amendment, modification, termination or waiver of this Note or
any provision hereof nor any consent to any departure by the Borrower herefrom
shall be effective unless the same is in writing and signed by the Lender and
then any such waiver or consent shall be effective only in the specific instance
and for the specific purpose for which given. No notice to or demand on the
Borrower shall entitle the Borrower to any other or further notice or demand in
similar or other circumstances.
10. THIS NOTE AND ALL RIGHTS AND OBLIGATIONS OF THE PARTIES HEREUNDER
SHALL BE GOVERNED BY AND CONSTRUED AND ENFORCED IN ACCORDANCE WITH THE LAWS OF
THE STATE OF GEORGIA.
11. This Note shall bind and inure to the benefit of the Borrower and
the Lender and their respective successors and assigns, except the Borrower
shall not have the right to assign or otherwise transfer any of its rights or
any interest of it under this Note without the prior written consent of the
Lender.
12. Any provision of this Note which is prohibited or unenforceable in
any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of
such prohibition or unenforceability without affecting the validity or
enforceability of the remainder of this Note or the enforceability of such
provision in any other jurisdiction.
<PAGE> 3
13. All notices, requests, demands, directions, declarations and other
communications provided for in this Note shall, except as otherwise expressly
provided, be mailed by registered or certified mail, return receipt requested,
or telegraphed, telecopied, or delivered in hand to the applicable party at its
address specified from time to time. The foregoing shall be effective when
deposited in the mails, postage prepaid, addressed as aforesaid and shall
whenever sent by telegram or telecopied or delivered in hand be effective when
received. Any party may change its address by a communication in accordance
herewith.
IN WITNESS WHEREOF, the Borrower and the Lender have caused this Note
to be duly executed as of the day and year first above written.
VAXCEL, INC.
By /s/ Mark J. Newman
-------------------------------------
Mark J. Newman
President & Chief Executive Officer
Accepted and agreed to by:
CYTRX CORPORATION
By /s/ Jack J. Luchese
-----------------------------------------
Jack J. Luchese
President & Chief Executive Officer
<PAGE> 1
EXHIBIT 10.8
OPTION AGREEMENT
THIS OPTION AGREEMENT (this "Agreement") is entered into as of this
27th day of January, 1999 (the "Effective Date") between Vaxcel, Inc., a
Delaware corporation having its offices at 154 Technology Parkway, Atlanta,
Georgia 30092 ("Vaxcel"), and Innovax Corporation, a Delaware corporation having
its offices at 28101 N. Ballard Drive, Suite F, Lake Forest, Illinois 60045
("Innovax").
BACKGROUND
Vaxcel has an exclusive worldwide license to oral microsphere
technology owned by Southern Research Institute ("SRI") and the UAB Research
Foundation ("UAB") (such technology, the "Oral Microsphere Technology"), and
under certain patents related to the Oral Microsphere Technology (the "Oral
Microsphere Technology Patents") pursuant to a License Agreement dated as of
August, 1998 between SRI and Vaxcel (the "License Agreement"). Innovax has
received and reviewed a copy of the License Agreement as provided by Vaxcel.
Innovax is a joint venture between Elan Corporation, plc. and Endorex
Corporation. Innovax desires to review certain confidential information relating
to the Oral Microsphere Technology and the Oral Microsphere Technology Patents
for the purpose of evaluating whether to become a sublicensee thereof, or to
take an assignment of the License Agreement pursuant to an option granted by
Vaxcel to Innovax hereunder. This Agreement documents the terms of the
disclosure of such confidential information and the grant of the option.
NOW, THEREFORE, in consideration of the premises and the covenants
contained herein, the parties hereto hereby agree as follows:
1. Vaxcel hereby grants to Innovax the access to, and the right to
review, the Confidential Information (as defined below), the Trade Secrets (as
defined below) and the Vaxcel Know-How (as defined below), all as related to the
Oral Microsphere Technology and the Oral Microsphere Technology Patents, for a
period commencing on the Effective Date and expiring on March 22, 1999 (such
period the "Evaluation Period") to determine whether (a) to become a sublicensee
of the Oral Microsphere Technology and the Oral Microsphere Technology Patents
for oral delivery of antigens to humans and animals or (b) to exercise the
Option (as defined below). Nothing in this Section 1 shall be deemed to
constitute a license to practice the claims of the Oral Microsphere Technology
Patents.
2. Vaxcel hereby grants to Innovax an option and right, but not the
obligation (the "Option") to enter into an Assignment and Assumption Agreement
with Vaxcel in substantially the form as Exhibit A attached hereto (the
"Assignment Agreement"), pursuant to which (a) Vaxcel shall assign to Innovax
all of its rights under the License
<PAGE> 2
Agreement and (b) Innovax shall assume all of Vaxcel's obligations under the
License Agreement that are not attributable to a breach by Vaxcel of the License
Agreement.
3. On the Effective Date, Innovax shall pay to Vaxcel an option fee of
$200,000 (the "Option Fee") payable (i) via wire transfer of immediately
available funds in accordance with written wiring instructions provided by
Vaxcel or (ii) by check sent via overnight delivery to the address set forth in
Section 24. The Option Fee is non-refundable; provided, however that, (i) if
Innovax exercises the Option, the Option Fee shall be credited against the
Exercise Price (as defined below) of the Option,(ii) if Innovax exercises the
Option but written consent from SRI is not obtained during the Evaluation Period
or any mutually agreed extension thereof for Vaxcel to assign the License
Agreement to Innovax, the Option Fee shall be fully refunded to Innovax and
(iii) if the License Agreement is terminated for any reason during the
Evaluation Period or any Extension thereof prior to the exercise of the Option,
the Option Fee shall be fully refunded to Innovax. If Vaxcel and Innovax are
unable to obtain SRI's written consent, if required, to the assignment of the
License Agreement and Vaxcel refunds the Option Fee, neither party shall be
bound by the provisions of this Agreement, except that Innovax shall continue to
be bound by the terms of Sections 10-15 hereof for the periods specified in such
Sections.
4. The initial term of the Option during which it may be exercised by
Innovax shall be the Evaluation Period. At any time prior to the expiration of
the Evaluation Period or any Extension (as defined below) thereof, Innovax may
extend the term of the Option for a period of five (5) days (each period, an
"Extension") by providing to Vaxcel written notice of its intention to do so and
by paying to Vaxcel an extension fee of $10,000 per Extension (each payment of
$10,000 an "Extension Fee" and collectively, the "Extension Fees") payable (i)
via wire transfer of immediately available funds in accordance with Vaxcel's
written wiring instructions or (ii) by check sent via overnight delivery to the
address set forth in Section 24. The maximum number of Extensions that may be
granted under this Section 4 is three (3), for an aggregate of fifteen (15)
days. The Extension Fees paid by Innovax, if any, are in addition to the
Exercise Price of the Option. The Option shall be of no further force or effect
after the expiration of the later of the Evaluation Period or any Extension
thereof for which Vaxcel has received the applicable Extension Fee.
5. The exercise price of the Option shall be $600,000 (the "Exercise
Price"). Innovax may exercise the Option at anytime during the Evaluation Period
and any Extension thereof by providing written notice of its intention to
exercise the Option and by paying to Vaxcel the Exercise Price (reduced by the
amount of the Option Fee), payable (i) via wire transfer of immediately
available funds in accordance with Vaxcel's written wiring instructions or (ii)
by check sent via overnight delivery to the address set forth in Section 24. In
addition, on the exercise date, Innovax shall execute and deliver to Vaxcel an
original counterpart signature page to the Assignment Agreement.
6. Concurrently with receipt by Vaxcel of the Exercise Price and an
original counterpart signature page to the Assignment Agreement executed by
Innovax, Vaxcel
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<PAGE> 3
shall execute and deliver to Innovax an original counterpart signature page to
the Assignment Agreement.
7. If the Option has not been exercised by Innovax before the
forty-fifth (45th) day of the Evaluation Period, Innovax and Vaxcel shall
promptly meet to discuss: (i) the progress of negotiations between Innovax and
SRI, (ii) the progress of Vaxcel in its commercially reasonable efforts to
obtain consent from SRI to the assignment to Innovax of the License Agreement,
and (iii) the likelihood that Innovax will require and be requesting an
Extension. If this meeting takes place outside an approximate 200 mile radius of
Atlanta, Georgia, Innovax will pay the reasonable travel expenses of Vaxcel.
8. At any time prior to the expiration of the Evaluation Period and any
Extension thereof, Vaxcel agrees to cooperate with Innovax and to use
commercially reasonable efforts to (i) assist Innovax with Innovax's negotiation
with SRI regarding certain terms of the License Agreement, (ii) obtain SRI's
written consent to the assignment to Innovax of the License Agreement and (iii)
assist SRI in obtaining the consent of UAB; provided, however, that the failure
to obtain UAB's consent shall not have any impact on the obligations of the
parties hereto. In addition, Vaxcel shall not discuss, negotiate, contract with
or otherwise enter into an arrangement with SRI that will in any way jeopardize
Innovax's negotiations with SRI regarding the Oral Microsphere Technology and
the Oral Microsphere Technology Patents; provided, however, that nothing in this
Section 8 shall prohibit Vaxcel from obtaining SRI's written consent to any
change of control of Vaxcel to be effected by a merger, consolidation, sale of
equity interests, sale of substantially all of Vaxcel's assets (other than any
of Vaxcel's rights under the License Agreement) or otherwise (collectively, a
"Vaxcel Change of Control").
9. During the Evaluation Period and any Extension thereof, Vaxcel
agrees that it will not sublicense, sell, assign, transfer, or otherwise dispose
of its rights under the License Agreement to any third party other than Innovax.
For purposes of this Agreement, any Vaxcel Change of Control shall not
constitute a sublicense, sale, assignment, transfer or other disposition or
encumbrance of any of Vaxcel's rights under the License Agreement; provided that
the surviving entity (if other than Vaxcel) acknowledges in writing its
obligations under this Agreement.
10. (a) All Trade Secrets, Confidential Information and Vaxcel Know-How
and all physical embodiments thereof received by Innovax from Vaxcel
during the term of this Agreement are confidential to and are (and will
remain) the sole and exclusive property of Vaxcel and/or its licensor,
SRI.
(b) At all times, both during the term of this Agreement and, if
the Option is not exercised by Innovax, after its expiration, Innovax
shall hold all Trade Secrets and Vaxcel Know-How in confidence, and
will not use (except as needed to exercise the rights granted
hereunder), copy or disclose such Trade Secrets or Vaxcel Know-How, or
any physical embodiment thereof.
-3-
<PAGE> 4
(c) At all times during the term of this Agreement and, if the
Option is not exercised by Innovax, for a period of five (5) years
following the expiration of the Evaluation Period and any Extension
thereof, Innovax shall hold the Confidential Information in confidence,
and will not use (except as needed to exercise the rights granted
hereunder), copy or disclose such Confidential Information, or any
physical embodiments thereof.
(d) If Innovax exercises the Option, Innovax hereby agrees
that it shall comply with the confidentiality provisions set forth in
Article IX of the License Agreement, as such License Agreement is
amended or modified by SRI and Innovax.
11. Trade Secrets, Confidential Information and Vaxcel Know-How shall
be maintained under secure conditions by Innovax, using reasonable security
measures and in any event not less than the same security measures used by
Innovax for protection of its own trade secrets, confidential information and
know-how of a similar kind. Innovax shall not remove, obscure, or deface any
proprietary legend relating to Vaxcel's rights on or from any tangible
embodiment of any Trade Secrets, Confidential Information or Vaxcel Know-How
without Vaxcel's prior written consent.
12. If Innovax is ordered by a court, administrative agency, or other
governmental body of competent jurisdiction to disclose Trade Secrets,
Confidential Information or Vaxcel Know-How, or if it is served with or
otherwise becomes aware of a motion or similar request that such an order be
issued, then Innovax will not be liable to Vaxcel for disclosure of Trade
Secrets, Confidential Information or Vaxcel Know-How required by such order if
Innovax complies with the following requirements: (a) if an already-issued order
calls for immediate disclosures, then Innovax shall immediately move for or
otherwise request a stay of such order to permit Vaxcel to respond; (b) Innovax
shall immediately notify Vaxcel of the motion or order by the most expeditious
possible means; and (c) Innovax shall join or agree to (or at a minimum shall
not oppose) a motion or similar request by Vaxcel for an order protecting the
secrecy of the Trade Secrets, Confidential Information and Vaxcel Know-How
including joining or agreeing to (or non-opposition to) a motion for leave to
intervene by Vaxcel.
13. Innovax shall immediately report to Vaxcel any action by any person
of which Innovax has knowledge of which constitutes a breach of Innovax's
obligations under Sections 10-15 hereof.
14. (a) For purposes of this Agreement, "Trade Secrets" means
information related to the Oral Microsphere Technology or the Oral
Microsphere Technology Patents which: (i) derives economic value,
actual or potential, from not being generally known to or readily
ascertainable by other persons who can obtain economic value from its
disclosure or use; and (ii) is the subject of efforts that are
reasonably under the circumstances to maintain its secrecy.
-4-
<PAGE> 5
(b) For purposes of this Agreement, "Vaxcel Know-How" means
any and all know-how of SRI for formulating, preparing, developing and
manufacturing a Vaccine (as defined in the License Agreement), whether
or not patentable, which has been disclosed or made available by SRI to
Vaxcel as "SRI Know-How" (as defined in the License Agreement) and
which Vaxcel has disclosed or made available to Innovax pursuant to
this Agreement or any other agreement. Vaxcel will clearly designate
and identify Vaxcel Know-How at the time of disclosure to Innovax.
(c) For purposes of this Agreement, "Confidential Information"
means information which is (i) confidential to the business of Vaxcel;
(ii) is designated and identified as such by Vaxcel; and (iii) is not a
Trade Secret. Confidential Information, Vaxcel Know-How and Trade
Secrets do not include: (i) any information that is at the time of
receipt by Innovax or thereafter becomes part of the public domain
other than as a result of the unauthorized actions of Innovax (through
publication or otherwise); (ii) any information that was independently
known to Innovax prior to receipt thereof from Vaxcel as evidenced by
written records of Innovax; (iii) any information that was disclosed to
Innovax by a third party having the right to disclose such information;
(iv) information that is subsequently developed independently by
Innovax without knowledge of or access to the Confidential Information,
Vaxcel Know-How or Trade Secrets.
15. During the Evaluation Period and any Extensions thereof, Vaxcel
shall make available to Innovax the Confidential Information, Trade Secrets and
Vaxcel Know-How for the sole purpose of evaluating whether to enter into a
sublicense or to exercise the Option for the Oral Microsphere Technology and the
Oral Microsphere Technology Patents.
16. Vaxcel represents and warrants to Innovax that:
(a) Vaxcel is a corporation duly organized, validly existing and in
good standing under the laws of the State of Delaware;
(b) subject to obtaining SRI's written consent, Vaxcel's rights
under the License Agreement are assignable to Innovax;
(c) the License Agreement is currently in full force and effect and
there has been no breach by Vaxcel (other than the breach by Zynaxis,
Inc. ("Zynaxis") of certain minimum annual payment obligations, which
breach has been cured by Vaxcel to SRI's satisfaction in connection
with the merger of Zynaxis into a subsidiary of Vaxcel) and no breach
is continuing as of the date hereof and no breach by Vaxcel shall exist
and be continuing during the Evaluation Period and any Extension
thereof;
-5-
<PAGE> 6
(d) neither the grant of the Option nor, subject to obtaining
SRI's prior written consent, the assignment of the License Agreement to
Innovax violates (or will violate) or conflicts (or will conflict) with
any term of any agreement between Vaxcel and any third party which
would adversely affect (i) Vaxcel's rights under the License Agreement
or (ii) Vaxcel's ability to assign the License Agreement to Innovax;
(e) Vaxcel has no knowledge of any threatened or pending
litigation, claim, suit or proceeding which would require the
disclosure of any Confidential Information, Vaxcel Know-How or Trade
Secrets.
(f) this Agreement is duly authorized by and is, and the
Assignment Agreement upon execution by Vaxcel will be, a legal and
binding obligation of Vaxcel, except as limited by (i) applicable
bankruptcy, insolvency, reorganization, moratorium and other laws of
general application affecting enforcement of creditors' rights
generally and (ii) laws relating to the availability of specific
performance, injunctive relief and other equitable remedies.
17. Innovax represents and warrants that:
(a) Innovax is a corporation duly organized, validly existing
and in good standing under the laws of the State of Delaware;
(b) this Agreement is duly authorized by and is, and the
Assignment Agreement upon execution by Innovax will be, a legal and
binding obligation of Innovax, except as limited by (i) applicable
bankruptcy, insolvency, reorganization, moratorium and other laws of
general application affecting enforcement of creditors' rights
generally and (ii) laws relating to the availability of specific
performance, injunctive relief and other equitable remedies.
18. EXCEPT AS EXPRESSLY SET FORTH IN SECTION 16 HEREIN, VAXCEL
MAKES NO EXPRESS OR IMPLIED WARRANTY, STATUTORY OR OTHERWISE, CONCERNING THE
ORAL MICROSPHERE TECHNOLOGY, THE ORAL MICROSPHERE TECHNOLOGY PATENTS OR ANY
INFORMATION PROVIDED TO INNOVAX BY VAXCEL OR ITS AGENTS. SPECIFICALLY, BUT
WITHOUT LIMITING THE FOREGOING, VAXCEL MAKES NO EXPRESS OR IMPLIED WARRANTY OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, QUALITY, USEFULNESS,
NONINFRINGEMENT OR TITLE OF OR TO THE ORAL MICROSPHERE TECHNOLOGY AND THE ORAL
MICROSPHERE TECHNOLOGY PATENTS. ALL PHYSICAL EMBODIMENTS OF THE ORAL MICROSPHERE
TECHNOLOGY AND ANY INFORMATION RELATED THERETO PROVIDED BY VAXCEL HEREUNDER ARE
PROVIDED ON AN "AS IS" BASIS. VAXCEL DOES NOT WARRANT THE ACCURACY OF ANY
INFORMATION INCLUDED IN TRADE SECRETS, CONFIDENTIAL INFORMATION OR VAXCEL
KNOW-HOW.
-6-
<PAGE> 7
19. This Agreement may not be assigned by any party hereto without the
prior written consent of the other party, and any attempt to assign this
Agreement shall be void; provided, however, that Vaxcel may assign this
Agreement to CytRx Corporation, a majority stockholder of Vaxcel. In addition, a
Vaxcel Change of Control shall not constitute an assignment and shall not
require the consent of Innovax, subject to the requirements of Section 9.
20. This Agreement may be executed in counterparts, each of which shall
be deemed an original, and all of which together shall be deemed one and the
same agreement.
21. This Agreement represents the complete agreement between the
parties hereto regarding the subject matter herein contained and supersedes any
and all prior and contemporaneous agreements and understandings between the
parties in regards hereto.
22. This Agreement may be amended only by a written instrument executed
by both parties hereto.
23. This Agreement shall be construed in accordance with the laws of
the State of Georgia, without regard to the conflicts of laws principals
thereof.
24. Any notice or communication authorized or required to be provided
hereunder shall be in writing and may be served by hand delivery, by certified
or registered first class mail, postage prepaid (return receipt requested) or by
overnight courier service. All notices sent in accordance with this Section
shall be effective upon delivery to the following address:
If to Vaxcel: Vaxcel, Inc.
154 Technology Parkway
Atlanta, Georgia 30092
Attention: President
with a copy to: Alston & Bird LLP
1201 West Peachtree Street
Atlanta, Georgia 30309-3424
Attention: George M. Maxwell, Jr.
If to Innovax: Innovax Corporation
28101 N. Ballard Drive
Suite F
Lake Forest, Illinois 60045
Attention:
---------------------
with a copy to: Elan Pharmaceutical Technologies, a division of Elan
Corporation, plc.
Lincoln House
Lincoln Place
Dublin 2, Ireland
Attention: Colin Sainsbury, Vice President & General
Counsel
and Endorex Corporation
28101 N. Ballard Drive
Suite F
Lake Forest, Illinois 60045
Attention: Michael S. Rosen, President and Chief
Executive Officer
and Brobeck, Phleger & Harrison LLP
1633 Broadway, 47th Floor
New York, NY 10019
Attention: Nigel L. Howard
[THE REST OF THIS PAGE INTENTIONALLY LEFT BLANK]
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<PAGE> 8
IN WITNESS WHEREOF, the undersigned have executed this Agreement as of
the date first written above.
Vaxcel, Inc.
By:
-------------------------
Name:
------------------------
Its:
-------------------------
Innovax Corporation
By:
--------------------------
Name:
-------------------------
Its:
-------------------------
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<PAGE> 9
EXHIBIT A
ASSIGNMENT AND ASSUMPTION AGREEMENT
THIS ASSIGNMENT AND ASSUMPTION AGREEMENT (this "Assignment") is entered
into as of this ____ day of ___________, 1999, by and between Vaxcel, Inc., a
Delaware corporation ("Vaxcel") and Innovax Corporation, a Delaware corporation
("Innovax").
Pursuant to that certain Option Agreement dated January ___, 1999
between Vaxcel and Innovax (the "Agreement"), Vaxcel granted an option (the
"Option") to Innovax pursuant to which Innovax, upon exercise of the Option in
accordance with the terms of the Agreement, shall acquire all of Vaxcel's
rights, and assume all of Vaxcel's obligations, under that certain License
Agreement dated as of August, 1998 (the "License Agreement"), between the
Southern Research Institute ("SRI") and Vaxcel, a copy of which is attached
hereto as Exhibit A. This Assignment documents the terms and conditions of the
assignment by Vaxcel to Innovax of all of Vaxcel's rights under the License
Agreement and the assumption by Innovax of all of Vaxcel's obligations under the
License Agreement that are not attributable to a breach by Vaxcel of the License
Agreement. Capitalized terms used but not otherwise defined in this Assignment
shall have the meaning ascribed to such terms in the Agreement.
In consideration of the mutual covenants set forth herein and in the
Agreement, and other good and valuable consideration, Vaxcel and Innovax hereby
agree as follows:
1. Vaxcel assigns, transfers and sets over unto Innovax, its
successors and assigns, all of Vaxcel' rights under (i) the License Agreement,
to have and to hold unto Innovax, its successors and assigns, from and after the
date hereof, subject to (A) the covenants, conditions, agreements, terms,
obligations, restrictions and other provisions set forth in the License
Agreement, including, without limitation, the confidentiality, proprietary
information and know-how provisions set forth in Sections 4.11 and 9.1 of the
License Agreement, as may be amended or modified by SRI and Innovax and (B) the
sublicense agreements set forth in Schedule 5(c) hereto, and (ii) the sublicense
agreements set forth in Schedule 5(c) hereto.
2. Innovax accepts such assignment and assumes and agrees to
perform, pay discharge and comply with all of the covenants, conditions,
agreements, terms, obligations and restrictions to be performed or complied with
on the part of Vaxcel under the License Agreement and the sublicense agreements
set forth in Schedule 5(c) hereto. In no event, however shall Innovax be deemed
to have assumed any obligation of Vaxcel that is attributable to Vaxcel's breach
of any provision of (i) the License Agreement or (ii) the sublicense agreements
set forth in Schedule 5(c) hereto or any agreements with any third parties
(including, without limitation, Third Parties as defined in the License
Agreement).
3. Vaxcel acknowledges receipt from Innovax of the Exercise
Price.
-9-
<PAGE> 10
4. The representations and warranties made by Vaxcel and Innovax
in the Agreement are incorporated and restated herein by reference.
5. Vaxcel represents and warrants that:
(a) except as set forth on Schedule 5(a), to the best of the
actual knowledge of Vaxcel, there are not any (i) actual claims by SRI or Vaxcel
against any third parties relating to such third party's infringement or
misappropriation of, or (ii) actual interference proceedings or actual
opposition hearings to which SRI or Vaxcel is a party and that relate to, the
Oral Microsphere Technology Patents or the Oral Microsphere Technology;
(b) except as set forth on Schedule 5(b), to the best of the
actual knowledge of Vaxcel, there are no written claims that the Oral
Microsphere Technology Patents or the Oral Microsphere Technology infringes any
patents, trade secrets, copyrights, trademarks or other intellectual property
rights of any third party, or of Vaxcel or its affiliates;
(c) except as set forth on Schedule 5(c), Vaxcel has not
granted any sublicenses under the License Agreement;
(d) neither Vaxcel nor SRI has amended or modified the License
Agreement or waived any material right under the License Agreement;
(e) except as set forth on Schedule 5(e), to the best of the
actual knowledge of Vaxcel, Vaxcel has not conceived, made or reduced to
practice any Improvements (as defined in the License Agreement) to the Oral
Microsphere Technology;
(f) Vaxcel, with Innovax's reasonable cooperation, has
obtained SRI's written consent in accordance with Section 13.8 of the License
Agreement, to the assignment of the License Agreement to Innovax, and a copy of
such consent is attached hereto as Exhibit B; and
(g) Vaxcel has paid all fees and other payments under the
License Agreement that are due and payable prior to the exercise date of the
Option, including, without limitation, (i) any payments or reimbursements due in
respect of patent prosecution or maintenance and (ii) the license payment of
$80,000 due to SRI on or before January 30, 1999, provided that the exercise
date does not occur prior to such date.
6. After delivery of this Assignment, Vaxcel shall, from time to
time, at Innovax's request, execute and deliver to Innovax as appropriate, such
other instruments of transfer and take such other actions as Innovax may
reasonably request to effectively assign to Innovax the License Agreement in
accordance with the Agreement and this Assignment.
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<PAGE> 11
7. Exhibit C attached hereto sets forth a list, as of the date of
this Agreement of the Oral Microsphere Technology Patents, the applicable
filings related thereto, and the filing fees and maintenance fees paid or due
and payable with respect to the Oral Microsphere Technology Patents.
8. Vaxcel represents and warrants that it has provided to Innovax
copies of or access to all written information in Vaxcel's possession as of the
date of this Assignment that has been requested by Innovax which is related to
any side effect, injury, toxicity or sensitivity reaction and the incident or
severity thereof in connection with any tests conducted by Vaxcel or its
sublicensees relating to the Oral Microsphere Technology.
9. After delivery of this Assignment, Vaxcel shall continue to
comply with the confidentiality, proprietary information and know-how provisions
set forth in the License Agreement, including, without limitation, Sections 4.11
and 9.1, for the duration and to the extent that such provisions apply (as of
the date hereof) to Vaxcel (as Receiving Party thereof) by their terms.
10. Schedule 10 sets forth a list of all of the SRI Know-How (as
defined in the License Agreement) that it has received from SRI.
11. Vaxcel shall promptly deliver to SRI (or if SRI consents in
writing, to Innovax) of any and all physical embodiments of any Confidential
Information, SRI Know-How or Trade Secrets that it has received from SRI and
that are in Vaxcel's possession as of the date of this Assignment.
12. This Assignment may not be modified, changed or supplemented
except by written instrument signed by each party hereto.
13. This Assignment shall be binding upon and inure to the benefit
of Innovax, Vaxcel and their respective successors and assigns.
14. This Assignment shall be construed in accordance with the laws
of the State of Georgia, without regard to the conflicts of laws principles
thereof.
15. EXCEPT AS EXPRESSLY SET FORTH IN THIS ASSIGNMENT, VAXCEL MAKES
NO EXPRESS OR IMPLIED WARRANTY, STATUTORY OR OTHERWISE, CONCERNING THE ORAL
MICROSPHERE TECHNOLOGY, THE ORAL MICROSPHERE TECHNOLOGY PATENTS OR ANY
INFORMATION PROVIDED TO INNOVAX BY VAXCEL OR ITS AGENTS. SPECIFICALLY, BUT
WITHOUT LIMITING THE FOREGOING, VAXCEL MAKES NO EXPRESS OR IMPLIED WARRANTY OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, QUALITY, USEFULNESS,
NONINFRINGEMENT (EXCEPT AS EXPRESSLY SET FORTH IN SECTION 5 OF THIS ASSIGNMENT)
OR TITLE OF OR TO THE ORAL MICROSPHERE TECHNOLOGY AND THE ORAL MICROSPHERE
TECHNOLOGY PATENTS.
16. This Assignment may be executed in counterparts, each of which
shall be deemed an original, and all of which together shall be deemed one and
the same agreement.
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<PAGE> 12
IN WITNESS WHEREOF, the undersigned have executed this Assignment as of
the date first written above.
Vaxcel, Inc.
By:
--------------------------
Name:
--------------------------
Its:
--------------------------
Innovax Corporation
By:
--------------------------
Name:
-------------------------
Its:
--------------------------
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<PAGE> 13
EXHIBIT AND SCHEDULE LIST
<TABLE>
<CAPTION>
Exhibit Reference Item
- ----------------- ----
<S> <C>
A License Agreement
B SRI Consent
C Oral Microsphere Technology Patents
Schedule Reference Item
- ------------------ ----
5(a) Third Party Infringement
5(b) Oral Microsphere Technology Infringement
5(c) Sublicenses
5(e) Improvements
10 SRI Know-How
</TABLE>
-13-
<PAGE> 1
EXHIBIT 23.1
CONSENT OF INDEPENDENT AUDITORS
We consent to the incorporation by reference in the Registration Statement on
Form S-8 No. 333-31733 pertaining to the Vaxcel, Inc. 1993 Stock Option Plan and
the Vaxcel, Inc. Replacement Plan for Zynaxis Options, of our report dated
March 9, 1999, with respect to the financial statements and schedule of Vaxcel,
Inc. included in the Annual Report (Form 10-K) for the year ended December 31,
1998.
/s/ Ernst & Young LLP
Atlanta, Georgia
March 29, 1999
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM SEC FORM
10-K OF VAXCEL INC. FOR THE YEAR ENDED DECEMBER 31, 1998 AND IS QUALIFIED IN ITS
ENTIRETY BY REFERENCE TO SUCH FORM 10-K.
</LEGEND>
<S> <C>
<PERIOD-TYPE> YEAR
<FISCAL-YEAR-END> DEC-31-1998
<PERIOD-START> JAN-01-1998
<PERIOD-END> DEC-31-1998
<CASH> 2,900
<SECURITIES> 0
<RECEIVABLES> 305,808
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 314,016
<PP&E> 145,264
<DEPRECIATION> 138,667
<TOTAL-ASSETS> 976,287
<CURRENT-LIABILITIES> 618,126
<BONDS> 0
0
0
<COMMON> 10,995
<OTHER-SE> 347,166
<TOTAL-LIABILITY-AND-EQUITY> 976,287
<SALES> 0
<TOTAL-REVENUES> 254,471
<CGS> 0
<TOTAL-COSTS> 0
<OTHER-EXPENSES> 5,247,760
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 66,786
<INCOME-PRETAX> (4,993,289)
<INCOME-TAX> 0
<INCOME-CONTINUING> (4,993,289)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (4,993,289)
<EPS-PRIMARY> (.45)
<EPS-DILUTED> (.45)
</TABLE>
